New Long-term Safety Data from the Completed Phase 3 SOLARIS Trial Support the Potential of Olanzapine LAI (TEV-'749) as the First Long-Acting Olanzapine Treatment Option for Schizophrenia with No PDSS Observed

Rhea-AI Summary

Teva Pharmaceuticals (NYSE:TEVA) announced promising long-term safety data from its Phase 3 SOLARIS trial for olanzapine LAI (TEV-'749), a potential first-in-class long-acting injectable olanzapine treatment for schizophrenia. The trial demonstrated no post-injection delirium/sedation syndrome (PDSS) events through Week 56, with 3,470 total injections administered.

Key findings include a consistent safety profile with other olanzapine formulations, with 74% of participants reporting treatment-emergent adverse events. Common side effects included weight increase (36%) and injection site reactions. The study showed stable symptom improvement and maintained clinical effectiveness, with participants experiencing a mean weight increase of 5.6kg over 48 weeks.

Additionally, new data on UZEDY®, Teva's approved extended-release injectable risperidone, showed a 2.89-day shorter hospital stay compared to Invega Sustenna®, potentially saving $3,200 per hospitalization. Teva plans to submit an NDA for olanzapine LAI in H2 2025.

Positive

• No post-injection delirium/sedation syndrome (PDSS) events observed through Week 56
• Long-term safety profile consistent with established olanzapine formulations
• Stable symptom improvement and maintained clinical effectiveness in PANSS and CGI-S scores
• UZEDY showed 2.89-day shorter hospital stays vs competitor, saving $3,200 per hospitalization
• Healthcare professionals showed high satisfaction with UZEDY (45% preferred over competitor's 38%)

Negative

• 74% of participants experienced treatment-emergent adverse events
• 36% of participants experienced weight increase as side effect
• 8% discontinuation rate due to treatment-emergent adverse events
• Mean weight increase of 5.6kg over 48 weeks in long-term participants

Insights

Pharmaceutical Research Analyst

Positive Phase 3 trial results show Teva's olanzapine LAI potentially addresses critical safety concerns, setting up NDA filing in 2025.

The long-term safety data from Teva's Phase 3 SOLARIS trial for olanzapine LAI (TEV-'749) represents a significant clinical breakthrough in schizophrenia treatment. The complete absence of post-injection delirium/sedation syndrome (PDSS) across 3,470 total injections addresses the primary safety concern that has limited the use of existing long-acting olanzapine formulations. This could potentially position TEV-'749 as the first viable long-acting olanzapine option without this serious side effect.

The safety profile demonstrated consistency with known olanzapine effects, with common adverse events including weight gain (36%), injection site reactions (induration 12%, pain 12%, erythema 10%), and somnolence (7%). The mean weight increase of 5.6kg over 48 weeks aligns with expectations for olanzapine. Importantly, the data showed maintained clinical effectiveness with stable improvements in PANSS scores and CGI-S measurements.

For UZEDY (risperidone), the comparative data showing a 2.89-day reduction in hospital stays versus Invega Sustenna represents a meaningful economic advantage, with estimated direct cost savings of $3,200 per hospitalization. Healthcare provider preferences favored UZEDY for ease of administration, initiation, and dosing characteristics.

With an NDA submission planned for H2 2025, TEV-'749 could fill a significant treatment gap in the schizophrenia market, where olanzapine's efficacy is well-established but long-acting formulations have been limited by PDSS concerns. This represents a potentially high-value addition to Teva's CNS portfolio, expanding their presence in the long-acting antipsychotic market beyond UZEDY.

• Through Week 56 in the SOLARIS trial, there were no suspected or confirmed post-injection delirium/sedation syndrome (PDSS) events observed with olanzapine LAI (TEV-'749) and its long-term systemic safety profile was consistent with other olanzapine formulations¹
• Additional new data comparing initiation of UZEDY^® (risperidone) versus Invega Sustenna^® (paliperidone palmitate) in hospitalized patients found that UZEDY was associated with shorter length of stay and was preferred overall by HCPs due to its dosing characteristics and ease of use¹
• Teva is committed to researching and developing innovative medicines that help address unmet needs for individuals living with complex mental health conditions
  

PARSIPPANY, N.J., and TEL AVIV, Israel, Sept. 20, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the presentation of 10 posters from its innovative schizophrenia medicines portfolio, including long-term safety data from the completed SOLARIS Phase 3 trial showing no incidence of post-injection delirium/sedation syndrome (PDSS) in study participants taking olanzapine LAI (TEV-'749), a once-monthly, long-acting injectable (LAI) subcutaneous formulation of olanzapine.¹ New data evaluating UZEDY^®, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, found that it was associated with a shorter length of hospitalization compared to a once-monthly intramuscular injection of Invega Sustenna^®.¹ No comparisons can be made regarding efficacy, safety, or any other clinical outcomes as this was not studied. The data were presented at the 2025 Psych Congress Annual Meeting, taking place from September 17–21, 2025, in San Diego, California.

“The first formulation of olanzapine was approved nearly 30 years ago and is now one of the most commonly prescribed daily oral medicines for the treatment of schizophrenia. With these long-term safety results from SOLARIS, olanzapine LAI (TEV-'749) has the potential to address a critical treatment gap by introducing a new era of long-acting olanzapine treatment,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “Separate from olanzapine LAI (TEV-'749), one of our latest UZEDY studies sought to understand its role during hospitalization, a delicate and vulnerable moment for people living with schizophrenia and their caregivers. The human impact of potentially shorter hospital stays, and healthcare cost savings are a true realization of Teva’s commitment to treatment innovations that help drive change for those living with complex neurological conditions.”

“These encouraging results from the SOLARIS trial show that olanzapine LAI (TEV-'749) has the potential to be the first long-acting olanzapine treatment option that alleviates the risk of PDSS. As a clinician, this is a critical development for people living with schizophrenia who may not prefer, or have difficulties adhering to daily oral treatment options,” said Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, Hempstead, NY and SOLARIS study coordinating investigator. “Olanzapine is a long-established treatment option for schizophrenia with a well-known safety and efficacy profile, and olanzapine LAI (TEV-'749) is building on that legacy with an innovative long-acting formulation that may help fill a significant gap in the current treatment landscape.”

Olanzapine LAI (TEV-'749) Data

Teva’s Phase 3 SOLARIS trial program (NCT05693935) comprised an 8-week, randomized, double-blind, placebo-controlled period (Period 1 [P1]) in 18–64-year-old participants (n=675) with schizophrenia, followed by an open-label, long-term safety period ≤48 weeks (P2). For P1, participants were randomized 1:1:1:1 to once-monthly olanzapine LAI (TEV-'749) (318mg, n=169; 425mg, n=169; 531mg, n=169) or placebo (n=168).¹ For P2, P1 olanzapine LAI (TEV-'749) participants retained their treatment; P1 placebo participants were re-randomized to olanzapine LAI (TEV-'749) dose-groups.¹

Through Week 56, an integrated long-term safety analysis from the double-blind and open-label periods demonstrated a systemic safety profile for olanzapine LAI (TEV-'749) that was consistent with second-generation antipsychotic class effects and other olanzapine formulations. Consistent with previous results, no PDSS events (suspected or confirmed) were reported (3,470 total injections).¹ Olanzapine LAI (TEV-'749) utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell that provides a controlled steady release of olanzapine.

Across olanzapine LAI (TEV-'749) groups, one or more treatment-emergent adverse events (TEAE) were reported in 449 (74%) participants with 50 (8%) experiencing TEAEs leading to trial discontinuation. Serious AEs were reported in 36 (6%) participants.¹ Most commonly reported TEAEs were weight increased (36%); injection site reactions (ISRs; induration [12%], pain [12%], erythema [10%], pruritus [7%]); and somnolence (7%).¹

Additionally, long-term effectiveness data from SOLARIS demonstrated long-term symptom improvement and maintained clinical effectiveness in adult participants taking olanzapine LAI (TEV-'749).¹ Across all olanzapine LAI (TEV-'749) doses, stable change from P2 baseline in Positive and Negative Syndrome Scale (PANSS) total and Clinical Global Impression-Severity (CGI-S) scale scores (mean change from baseline: -7.2 and -0.5, respectively) were observed. Olanzapine LAI (TEV-'749) also improved patient functioning scores, with a 4.6-point mean increase in Personal and Social Performance Scale (PSP) score from P2 baseline.¹

A weight and metabolic analysis of the SOLARIS trial found that long-term metabolic safety data for olanzapine LAI (TEV-'749) were consistent with currently available olanzapine formulations.¹ The overall mean weight increase from baseline in participants who received olanzapine LAI (TEV-'749) for ≥48 weeks (n=137) was 5.6kg, which was comparable to those reported for oral and intramuscular olanzapine formulations. By week 32, all olanzapine LAI (TEV-'749) and placebo groups reached a similar mean weight increase versus baseline, which thereafter remained stable through week 48.¹

UZEDY Data

In a retrospective observational cohort study that included HCPs who prescribed UZEDY or Invega Sustenna^® (paliperidone palmitate) for patients with schizophrenia during hospitalization, found that the initiation of UZEDY (n=137) was associated with shorter hospital stays compared to Invega Sustenna^® (n=94).¹ UZEDY was associated with a 2.89-day shorter length of stay compared with Invega Sustenna^® (12.57 [SD:10.03] vs 15.46 days [10.15], P=0.033), which translates to estimated direct cost savings of $3,200 per hospitalization.¹ UZEDY was favored over Invega Sustenna^® for ease of administration (45% vs 34%), initiation (47% vs 33%), dosing characteristics (40% vs 38%), and subcutaneous injection features (40% vs 33%). Overall, 45% preferred UZEDY, while 38% preferred Invega Sustenna^®.¹

Additionally, a real-world qualitative study of 56 healthcare professionals (20 physicians, 23 nurse practitioners/physician assistants [NP/PAs], 13 registered nurses [RNs]) show high levels of satisfaction with UZEDY.¹ Additional findings include:

• Satisfaction: For physicians, the most common areas of satisfaction were familiarity with UZEDY (87%) and subcutaneous injection (67%). For NP/PAs, they were effectiveness (42%), no loading dose (26%), and tolerability (26%).¹
• Initiation regimen: Across HCP types, attributes of UZEDY most reported as slightly/significantly better when compared with other LAIs included lack of required loading dose (89%) and subcutaneous administration (86%).¹
• Plasma concentration: UZEDY was more often reported as slightly/significantly better compared to other LAI options by NP/PAs (87%) and physicians (79%) than by RNs (69%) when asked about plasma concentrations.¹
  

No comparisons can be made regarding efficacy, safety, or any other clinical outcomes as this was not studied. See below for additional Important Safety Information for UZEDY.

Below is the full set of schizophrenia data presented by Teva at Psych Congress 2025:

Olanzapine LAI (TEV-'749):

• (De novo) Long-Term Safety of Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) in Schizophrenia: Results From the Phase 3 SOLARIS Trial
• (De novo) Long-Term Effectiveness With Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) in Adults With Schizophrenia: Results From Up to 48 Weeks Open Label Treatment in the Phase 3 SOLARIS Trial
• (De novo) Evaluating Long-Term Weight Gain and Other Metabolic Changes With Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) in Adults With Schizophrenia: Results From the Phase 3 SOLARIS Trial
• (De novo) Real-World Evidence of the Burden of Non-Adherence to Oral Olanzapine on Relapse and Healthcare Resource Utilization Among Adults With Schizophrenia
• (De novo) Clinician Perspectives on Olanzapine-Associated Adverse Event Mitigation Strategies for Schizophrenia Treatment: Results From the SONAR (Survey on Olanzapine Needs and Attitudes Research) Study
• (De novo) Clinician Perspectives on Long-Acting Injectable Olanzapine Treatment Barriers and Unmet Needs From the SONAR (Survey on Olanzapine Needs and Attitudes Research) Study

UZEDY (risperidone):

• (De novo) Inpatient Length of Stay and Healthcare Professional Preferences for Initiating TV-46000, a Long-Acting Subcutaneous Antipsychotic, or Intramuscular Paliperidone Palmitate in Patients Hospitalized With Schizophrenia
• (De novo) Pharmacokinetic-Pharmacodynamic Modeling of Switching From Aripiprazole Monohydrate to TV-46000, a Long-Acting Subcutaneous Risperidone, in a Virtual Population of Patients With Schizophrenia
• (De novo) Real-World Experiences Using TV-46000 in Adults With Schizophrenia: A Qualitative Study of Healthcare Professionals
• (De novo) Time-Varying Predictors of Relapse in Patients Treated With TV-46000 or Placebo in the RISE Study: A Machine-Learning Analysis

Olanzapine LAI (TEV-'749) is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine and is not approved by any regulatory authority for any use, and its safety and efficacy are not established. Teva Pharmaceuticals plans to proceed with an NDA submission in H2 2025.

Olanzapine LAI (TEV-'749) and UZEDY utilize SteadyTeq™, a copolymer technology proprietary to MedinCell that provides a controlled steady release of olanzapine and risperidone, respectively.

UZEDY was approved in the U.S. for the treatment of schizophrenia in adults in 2023.¹

Invega Sustenna^® is a product of Janssen Pharmaceuticals, Inc.

Teva Investor Call

Teva will hold an investor call and live webcast on Monday, September 22, 2025, at 11:00 a.m. ET to discuss these data. During the conference call, Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer, will discuss new data presented for olanzapine LAI (TEV-'749) positive Phase 3 SOLARIS trial results at the 2025 Psych Congress Annual Meeting. To access a live webcast of the presentation, visit Teva’s Investor Relations website at https://ir.tevapharm.com/Events-and-Presentations. An archived version of the webcast will be available within 24 hours after the end of the live discussion.

About UZEDY
UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for the treatment of schizophrenia in adults. In clinical trials, UZEDY significantly reduced the risk of schizophrenia relapse.^1,2 UZEDY administers risperidone through copolymer technology under license from MedinCell that allows for rapid absorption and sustained release after subcutaneous injection. UZEDY is the only long-acting, subcutaneous formulation of risperidone available in both one- and two-month dosing intervals.² For full prescribing information, visit https://www.uzedy.com/globalassets/uzedy/prescribing-information.pdf.

About Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS)
SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-65 years) with schizophrenia.¹ For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (TEV-'749) (low, medium or high dose) or placebo in a 1:1:1:1 ratio.¹ For period two, which will last for up to 48 weeks, patients who completed period one were randomized and equally allocated to one of the three olanzapine LAI (TEV-'749) treatment groups.¹ The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively.¹ The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI (TEV-'749) in adult patients with schizophrenia.¹ A key secondary objective was to further evaluate the efficacy of olanzapine LAI (TEV-'749) based on additional parameters in adult patients with schizophrenia.¹ A secondary objective of period two of the study is to evaluate the safety and tolerability of olanzapine LAI (TEV-'749) in adult patients with schizophrenia.¹

About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.³ Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.^3,4,5 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 3.5 million people in the U.S. are currently diagnosed with the condition.^4,5 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women.⁵ The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.⁵ Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.^6,7,8 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.^3,4,5,6,7,8

INDICATION AND USAGE

UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for the treatment of schizophrenia in adults.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. UZEDY is not approved for use in patients with dementia-related psychosis and has not been studied in this patient population.

See below for additional Important Safety Information.

IMPORTANT SAFETY INFORMATION CONTINUED

CONTRAINDICATIONS: UZEDY is contraindicated in patients with a known hypersensitivity to risperidone, its metabolite, paliperidone, or to any of its components. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone or paliperidone.

WARNINGS AND PRECAUTIONS

Cerebrovascular Adverse Reactions: In trials of elderly patients with dementia-related psychosis, there was a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, in patients treated with oral risperidone compared to placebo. UZEDY is not approved for use in patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status including delirium, and autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If NMS is suspected, immediately discontinue UZEDY and provide symptomatic treatment and monitoring.

Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to predict which patients will develop the syndrome. Whether antipsychotic drug products differ in their potential to cause TD is unknown.

The risk of developing TD and the likelihood that it will become irreversible are believed to increase with the duration of treatment and the cumulative dose. The syndrome can develop, after relatively brief treatment periods, even at low doses. It may also occur after discontinuation. TD may remit, partially or completely, if antipsychotic treatment is discontinued. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome, possibly masking the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

If signs and symptoms of TD appear in a patient treated with UZEDY, drug discontinuation should be considered. However, some patients may require treatment with UZEDY despite the presence of the syndrome. In patients who do require chronic treatment, use the lowest dose and the shortest duration of treatment producing a satisfactory clinical response. Periodically reassess the need for continued treatment.

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.

Hyperglycemia and diabetes mellitus (DM): in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with atypical antipsychotics, including risperidone. Patients with an established diagnosis of DM who are started on atypical antipsychotics, including UZEDY, should be monitored regularly for worsening of glucose control. Patients with risk factors for DM (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics, including UZEDY, should undergo fasting blood glucose (FBG) testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics, including UZEDY, should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics, including UZEDY, should undergo FBG testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic, including risperidone, was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of risperidone.

Dyslipidemia has been observed in patients treated with atypical antipsychotics.

Weight gain has been observed with atypical antipsychotic use. Monitoring weight is recommended.

Hyperprolactinemia: As with other drugs that antagonize dopamine D₂ receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.

Orthostatic Hypotension and Syncope: UZEDY may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope. UZEDY should be used with particular caution in patients with known cardiovascular disease, cerebrovascular disease, and conditions which would predispose patients to hypotension and in the elderly and patients with renal or hepatic impairment. Monitoring of orthostatic vital signs should be considered in all such patients, and a dose reduction should be considered if hypotension occurs. Clinically significant hypotension has been observed with concomitant use of oral risperidone and antihypertensive medication.

Falls: Antipsychotics, including UZEDY, may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other fall-related injuries. Somnolence, postural hypotension, motor and sensory instability have been reported with the use of risperidone. For patients, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects, assess the risk of falls when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotic agents, including risperidone. In patients with a pre-existing history of a clinically significant low white blood cell count (WBC) or absolute neutrophil count (ANC) or a history of drug-induced leukopenia or neutropenia, perform a complete blood count (CBC) frequently during the first few months of therapy. In such patients, consider discontinuation of UZEDY at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue UZEDY in patients with ANC < 1000/mm³) and follow their WBC until recovery.

Potential for Cognitive and Motor Impairment: UZEDY, like other antipsychotics, may cause somnolence and has the potential to impair judgement, thinking, and motor skills. Somnolence was a commonly reported adverse reaction associated with oral risperidone treatment. Caution patients about operating hazardous machinery, including motor vehicles, until they are reasonably certain that treatment with UZEDY does not affect them adversely.

Seizures: During premarketing studies of oral risperidone in adult patients with schizophrenia, seizures occurred in 0.3% of patients (9 out of 2,607 patients), two in association with hyponatremia. Use UZEDY cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Antipsychotic drugs, including UZEDY, should be used cautiously in patients at risk for aspiration.

Priapism has been reported during postmarketing surveillance for other risperidone products. A case of priapism was reported in premarket studies of UZEDY. Severe priapism may require surgical intervention.

Body temperature regulation. Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Both hyperthermia and hypothermia have been reported in association with oral risperidone use. Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use UZEDY with caution in patients who experience these conditions.

ADVERSE REACTIONS
The most common adverse reactions with risperidone (≥5% and greater than placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.

The most common injection site reactions with UZEDY (≥5% and greater than placebo) were pruritus and nodule.

DRUG INTERACTIONS

• Carbamazepine and other strong CYP3A4 inducers decrease plasma concentrations of risperidone.
• Fluoxetine, paroxetine, and other strong CYP2D6 inhibitors increase risperidone plasma concentration.
• Due to additive pharmacologic effects, the concomitant use of centrally-acting drugs, including alcohol, may increase nervous system disorders.
• UZEDY may enhance the hypotensive effects of other therapeutic agents with this potential.
• UZEDY may antagonize the pharmacologic effects of dopamine agonists.
• Concomitant use with methylphenidate, when there is change in dosage of either medication, may increase the risk of extrapyramidal symptoms (EPS)

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause EPS and/or withdrawal symptoms in neonates with third trimester exposure. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including UZEDY, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinicaland-research-programs/pregnancyregistry/.

Lactation: Infants exposed to risperidone through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and EPS.

Fertility: UZEDY may cause a reversible reduction in fertility in females.

Pediatric Use: Safety and effectiveness of UZEDY have not been established in pediatric patients.

Renal or Hepatic Impairment: Carefully titrate on oral risperidone up to at least 2 mg daily before initiating treatment with UZEDY.

Patients with Parkinson’s disease or dementia with Lewy bodies can experience increased sensitivity to UZEDY. Manifestations and features are consistent with NMS.

Please see the full Prescribing Information for UZEDY, including Boxed WARNING.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This Press Release and the presentation at the conference may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop olanzapine LAI (TEV-‘749) for the treatment of adult patients diagnosed with schizophrenia; our ability to successfully develop and commercialize UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia; our ability to successfully compete in the marketplace, including our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

References: 

1. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
2. UZEDY^® (risperidone) extended-release injectable suspension, for subcutaneous injection Current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc.
3. Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia.
4. Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.
5. Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.
6. Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223.
7. Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.
8. Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615.

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com
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TevaIR@Tevapharm.com

FAQ

What were the key findings of Teva's Phase 3 SOLARIS trial for olanzapine LAI (TEV-'749)?

The trial showed no post-injection delirium/sedation syndrome (PDSS) through Week 56, with 74% of participants experiencing treatment-emergent adverse events. The safety profile was consistent with other olanzapine formulations.

How does UZEDY compare to Invega Sustenna in hospital stay duration?

UZEDY was associated with a 2.89-day shorter hospital stay compared to Invega Sustenna, resulting in estimated cost savings of $3,200 per hospitalization.

What are the main side effects reported in the SOLARIS trial for olanzapine LAI?

The most common side effects were weight increase (36%) and injection site reactions including induration (12%), pain (12%), erythema (10%), and pruritus (7%).

When does Teva plan to submit the NDA for olanzapine LAI (TEV-'749)?

Teva plans to submit the New Drug Application (NDA) for olanzapine LAI in the second half of 2025.

What was the weight gain observed in long-term olanzapine LAI participants?

Participants who received olanzapine LAI for ≥48 weeks (n=137) showed an overall mean weight increase of 5.6kg, comparable to oral and intramuscular olanzapine formulations.