Sage Therapeutics Announces Second Quarter 2024 Financial Results and Highlights Pipeline and Business Progress
Sage Therapeutics reported Q2 2024 financial results and pipeline updates. ZURZUVAE collaboration revenue reached $7.4 million, a 19% increase from Q1. Over 1,400 prescriptions were shipped, nearly doubling from Q1. Dalzanemdor (SAGE-718) topline data for Alzheimer's and Huntington's disease studies are expected in late 2024. The DIMENSION study's primary endpoint was adjusted to the Symbol Digit Modalities Test. SAGE-324 failed to meet the primary endpoint for essential tremor, leading to termination of the clinical program. Cash position stood at $647 million as of June 30, 2024. The company expects its current financial resources to support operations into 2026.
Sage Therapeutics ha riportato i risultati finanziari del secondo trimestre 2024 e aggiornamenti sulla pipeline. I ricavi della collaborazione con ZURZUVAE hanno raggiunto i 7,4 milioni di dollari, con un aumento del 19% rispetto al primo trimestre. Sono state spedite oltre 1.400 prescrizioni, quasi raddoppiando rispetto al primo trimestre. I dati principali per Dalzanemdor (SAGE-718) relativi agli studi su Alzheimer e malattia di Huntington sono attesi per la fine del 2024. L'endpoint primario dello studio DIMENSION è stato modificato in base al Symbol Digit Modalities Test. SAGE-324 non ha raggiunto l’endpoint primario per il tremore essenziale, portando alla chiusura del programma clinico. La posizione di cassa si attestava a 647 milioni di dollari al 30 giugno 2024. L'azienda prevede che le risorse finanziarie attuali supportino le operazioni fino al 2026.
Sage Therapeutics reportó los resultados financieros del segundo trimestre de 2024 y actualizaciones sobre su pipeline. Los ingresos por colaboración con ZURZUVAE alcanzaron los 7.4 millones de dólares, un aumento del 19% en comparación con el primer trimestre. Se enviaron más de 1,400 recetas, casi duplicando la cifra del primer trimestre. Se esperan los datos principales de Dalzanemdor (SAGE-718) para los estudios de Alzheimer y enfermedad de Huntington a finales de 2024. El objetivo primario del estudio DIMENSION se ajustó al Symbol Digit Modalities Test. SAGE-324 no logró cumplir con el objetivo primario para el temblor esencial, lo que llevó a la finalización del programa clínico. La posición de efectivo fue de 647 millones de dólares al 30 de junio de 2024. La compañía espera que sus recursos financieros actuales respalden las operaciones hasta 2026.
Sage Therapeutics는 2024년 2분기 재무 결과 및 파이프라인 업데이트를 발표했습니다. ZURZUVAE와의 협력 수익은 740만 달러에 이르렀으며, 이는 1분기 대비 19% 증가한 수치입니다. 1,400건 이상의 처방이 발송되어 1분기 거의 두 배로 증가했습니다. Dalzanemdor (SAGE-718)의 알츠하이머 및 헌팅턴병 연구에 대한 주요 데이터는 2024년 말에 발표될 예정입니다. DIMENSION 연구의 주요 목표는 Symbol Digit Modalities Test로 조정되었습니다. SAGE-324는 필수 떨림에 대한 주요 목표를 달성하지 못해 임상 프로그램이 종료되었습니다. 2024년 6월 30일 기준 현금 보유액은 6억 4,700만 달러입니다. 회사는 현재의 재무 자원이 2026년까지 운영을 지원할 것으로 예상하고 있습니다.
Sage Therapeutics a annoncé les résultats financiers du deuxième trimestre 2024 ainsi que des mises à jour concernant sa pipeline. Les revenus de collaboration pour ZURZUVAE ont atteint 7,4 millions de dollars, soit une augmentation de 19 % par rapport au premier trimestre. Plus de 1 400 prescriptions ont été expédiées, presque le double par rapport au premier trimestre. Les données principales de Dalzanemdor (SAGE-718) pour les études sur la maladie d'Alzheimer et la maladie de Huntington sont attendues pour fin 2024. L'objectif principal de l'étude DIMENSION a été ajusté au Symbol Digit Modalities Test. SAGE-324 n'a pas réussi à atteindre l'objectif principal pour le tremblement essentiel, entraînant l'arrêt du programme clinique. La position de liquidités s'élevait à 647 millions de dollars au 30 juin 2024. La société s'attend à ce que ses ressources financières actuelles soutiennent les opérations jusqu'en 2026.
Sage Therapeutics hat die Finanzergebnisse für das zweite Quartal 2024 und Aktualisierungen zur Pipeline bekannt gegeben. Die Kooperationseinnahmen von ZURZUVAE beliefen sich auf 7,4 Millionen Dollar, was einem Anstieg von 19 % gegenüber dem ersten Quartal entspricht. Über 1.400 Verschreibungen wurden verschickt, was nahezu einer Verdopplung im Vergleich zum ersten Quartal entspricht. Die wichtigsten Daten für Dalzanemdor (SAGE-718) hinsichtlich der Studien zu Alzheimer und Chorea Huntington werden Ende 2024 erwartet. Der primäre Endpunkt der DIMENSION-Studie wurde auf den Symbol Digit Modalities Test angepasst. SAGE-324 konnte den primären Endpunkt für essentiellen Tremor nicht erreichen, was zur Beendigung des klinischen Programms führte. Zum 30. Juni 2024 betrug die Liquidität 647 Millionen Dollar. Das Unternehmen erwartet, dass seine aktuellen finanziellen Ressourcen die Betriebsabläufe bis 2026 unterstützen werden.
- ZURZUVAE collaboration revenue increased 19% to $7.4 million in Q2 2024
- ZURZUVAE prescriptions shipped nearly doubled to over 1,400 in Q2 2024
- 80% of commercial lives covered by payor policies for ZURZUVAE in PPD
- Cash position of $647 million expected to support operations into 2026
- R&D expenses decreased to $62.6 million in Q2 2024 from $97.2 million in Q2 2023
- SG&A expenses reduced to $56.0 million in Q2 2024 from $75.6 million in Q2 2023
- Net loss decreased to $102.9 million in Q2 2024 from $160.3 million in Q2 2023
- SAGE-324 failed to meet primary endpoint in essential tremor study
- Clinical development for SAGE-324 in essential tremor terminated
- ZULRESSO revenue declined to $0.6 million in Q2 2024 from $2.5 million in Q2 2023
- No milestone payments from collaborations anticipated for the remainder of 2024
Insights
Sage Therapeutics' Q2 2024 results present a mixed picture. The company reported
The prescription growth for ZURZUVAE is impressive, with over 1,400 prescriptions shipped in Q2, nearly doubling from Q1. This suggests strong market adoption, particularly among OBGYNs who accounted for over
However, the company's cash position has decreased from
The net loss of
The company's guidance that current cash will support operations into 2026 provides some reassurance, but investors should monitor the burn rate closely. The lack of anticipated milestone payments in 2024 puts more pressure on ZURZUVAE's performance to drive revenue growth.
The clinical development updates in Sage's Q2 report are significant. The adjustment of the primary endpoint in the DIMENSION study for dalzanemdor (SAGE-718) from the HD-CAB composite to the Symbol Digit Modalities Test (SDMT) is noteworthy. This change, based on the SURVEYOR Study results, suggests a more focused approach to measuring cognitive improvement in Huntington's Disease patients.
The failure of SAGE-324 in the KINETIC 2 study for Essential Tremor is a major setback. The lack of statistically significant improvements over placebo led to the termination of the ET program, which will likely impact the company's pipeline valuation.
On a positive note, the ongoing studies for dalzanemdor in both Huntington's Disease (DIMENSION) and Alzheimer's Disease (LIGHTWAVE) represent significant potential. With topline data expected in late 2024, these studies could be pivotal for Sage's neurodegenerative disease portfolio.
The Fast Track and Orphan Drug Designations for dalzanemdor in HD treatment highlight its potential importance. However, investors should be cautious as these designations don't guarantee clinical success or regulatory approval.
Overall, while the SAGE-324 setback is disappointing, the focus on dalzanemdor and its potential in multiple neurodegenerative disorders could still provide significant value if clinical trials prove successful.
The early commercial performance of ZURZUVAE is promising. The
Payor coverage is important for ZURZUVAE's success. The 80% coverage of commercial lives, mostly without complex restrictions, is a positive sign. However, ongoing Medicaid reviews and discussions with the third national PBM indicate that full market access is still a work in progress.
The ZURZUVAE For You patient support program, with most commercially insured patients paying no copay, could be a significant driver of adoption. This strategy may help overcome initial barriers to treatment but could impact profit margins.
The decline in ZULRESSO sales (
The termination of the SAGE-324 program for Essential Tremor narrows Sage's pipeline focus. While disappointing, this allows for resource reallocation to more promising areas like dalzanemdor's development in Huntington's and Alzheimer's diseases.
Achieved
More than 1,400 prescriptions shipped and delivered during the second quarter of 2024, nearly doubling from the first quarter
Dalzanemdor (SAGE-718) topline data from the LIGHTWAVE (Alzheimer’s Disease) and DIMENSION (Huntington’s Disease) Studies expected in late 2024; primary endpoint for DIMENSION Study adjusted from HD-CAB composite to the Symbol Digit Modalities Test (SDMT)
SAGE-324 did not meet the primary endpoint in participants with essential tremor (ET); Sage and Biogen terminated clinical development for the ET program
Cash, cash equivalents and marketable securities of
“We are pleased with the strength of ZURZUVAE’s early commercial launch performance and its positive, real-world impact on women suffering from PPD. Supported by several tailwinds, including increasing demand among a mix of providers, particularly OBGYNs, we believe ZURZUVAE is well-positioned to become the first line therapy and standard of care for women with PPD,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “While we are deeply disappointed by the results from the KINETIC 2 study and for the essential tremor community, we remain focused on progressing our pipeline and look forward to additional clinical data readouts expected in late 2024.”
Second Quarter 2024 Portfolio Updates
Sage is advancing a portfolio of internally discovered novel chemical entities with the potential to become differentiated products designed to improve brain health by targeting the GABAA and NMDA receptor systems. Dysfunction in these systems is thought to be at the core of numerous neuropsychiatric disorders.
Postpartum Depression Commercial Products
ZURZUVAE was approved by the FDA in August 2023 as the first-and-only oral treatment specifically indicated for adults with postpartum depression (PPD). ZURZUVAE was made commercially available in December 2023. ZURZUVAE is being developed and commercialized in collaboration with Biogen Inc. Sage also commercializes ZULRESSO® (brexanolone) CIV injection in the treatment of PPD.
ZURZUVAE
Sage and its collaborator, Biogen, are focused on the goal of establishing ZURZUVAE as the first line therapy and standard of care for women with PPD. The companies are utilizing a specialty pharmacy distribution model by which ZURZUVAE is shipped directly to women with PPD who are prescribed the treatment.
As of the second quarter ended June 30, 2024, the following results had been achieved:
-
$7.4 million 19% increase from the first quarter. Collaboration revenues represent50% of the net revenues recorded when Biogen ships ZURZUVAE to the distributors. -
Approximately 2,000 prescriptions written in the second quarter, representing a greater than
60% increase from the first quarter. -
More than 1,400 prescriptions were shipped and delivered in the second quarter, representing a greater than
95% increase from the first quarter.
Sage and Biogen field sales teams are engaging in promotional dialogues with HCPs who actively identify and treat women with PPD. In the second quarter of 2024, OBGYNs accounted for more than
The companies continue to advance discussions with national, regional and government payors to advocate for broad and equitable access to ZURZUVAE for women with PPD with minimal restrictions and expect formulary discussions to continue over the course of 2024.
-
As of late July 2024, approximately
80% of all commercial lives are covered by payor policies in PPD, with the majority having no step therapy or complex prior authorizations, including two of three national PBMs who have developed coverage policies for ZURZUVAE in the treatment of women with PPD. Conversations with the third national PBM continue to progress. - Medicaid reviews are ongoing, with additional states, including several of the largest states, completing reviews during the second quarter of 2024. The majority of Medicaid coverage decisions have already been made and the Company expects the remainder of decisions to occur in the second half of 2024.
- In the second quarter of 2024, the majority of prescriptions shipped were covered by commercial or government payors.
Sage and Biogen’s patient support program for women with PPD, ZURZUVAE For You, provides educational resources, help with understanding insurance coverage and assistance navigating the prescription fulfillment process. The program also includes financial assistance, such as a copay assistance program and product at no cost, for eligible patients. In the second quarter of 2024, the vast majority of commercially insured patients using the ZURZUVAE savings card paid no copay.
The Company expects the following milestones for ZURZUVAE in 2024:
-
2024:
- Ongoing commercialization of ZURZUVAE in the treatment of women with PPD
- Present analyses of real-world evidence for ZURZUVAE including health economics and patient reported outcomes
Pipeline
Dalzanemdor (SAGE-718)
Dalzanemdor (SAGE-718), the Company’s first-in-class NMDA receptor positive allosteric modulator (PAM), is in development as a potential oral therapy for cognitive impairment associated with neurodegenerative disorders. Dalzanemdor has received Fast Track Designation and Orphan Drug Designation (ODD) from the FDA, and Orphan Drug Designation from the European Medicines Agency (EMA) for the potential treatment of Huntington’s Disease. Dalzanemdor has also been awarded an Innovation Passport Designation for cognitive impairment associated with HD and entry into the Innovative Licensing and Access Pathway (ILAP) by the
Sage is advancing a clinical program for dalzanemdor with ongoing Phase 2 studies, including the DIMENSION study in people with cognitive impairment associated with Huntington’s Disease (HD), the lead indication for dalzanemdor, and the LIGHTWAVE study in people with mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s Disease (AD).
In June, Sage announced topline results from the SURVEYOR Study. The SURVEYOR Study met its primary endpoint demonstrating a statistically significant difference as measured by the HD-Cognitive Assessment Battery (HD-CAB) composite score at baseline between healthy participants and participants with Huntington’s Disease (HD) prior to any treatment with dalzanemdor (SAGE-718) or placebo, further underscoring the cognitive impact of HD. For participants with HD that received dalzanemdor or placebo, dalzanemdor was generally well-tolerated with no new safety signals observed. There was a small numerical difference observed between dalzanemdor and placebo on the HD-CAB composite score at Day 28. Other prespecified analyses suggested the potential for directionally positive signals in a number of individual component tests of the HD-CAB and in some functional assessments.
Based on the review of data from the SURVEYOR Study and other relevant information, the Company has decided to adjust the primary endpoint in the ongoing placebo-controlled DIMENSION Study in HD from the HD-CAB composite to the Symbol Digit Modalities Test (SDMT), one of the cognitive tests included in the composite. Other secondary endpoints include additional measures of cognition, functioning and safety. Topline data from the DIMENSION Study are expected in late 2024.
Ongoing studies in the dalzanemdor clinical program include:
- DIMENSION (CIH-201) Study: The DIMENSION Study is a double-blind, placebo-controlled Phase 2 study in people with cognitive impairment associated with HD. The study is designed to evaluate the efficacy and safety of once-daily dalzanemdor dosed over three months.
- PURVIEW (CIH-301) Study: The PURVIEW Study is an open-label Phase 3 safety study designed to evaluate the long-term safety and tolerability of dalzanemdor in participants with HD.
- LIGHTWAVE (CNA-202) Study: The LIGHTWAVE Study is a double-blind, placebo-controlled Phase 2 study of dalzanemdor in people with MCI and mild dementia due to AD. The study is designed to evaluate the safety and efficacy of dalzanemdor dosed over a 12-week period.
The Company expects the following milestones for dalzanemdor in 2024:
-
Late 2024:
- Report topline data from LIGHTWAVE Study in people with MCI and mild dementia due to AD
- Report topline data from DIMENSION Study in people with HD cognitive impairment
-
2024:
- Present additional analyses of data from the clinical development program as well as disease state and burden of disease research in HD and/or AD
SAGE-324
SAGE-324 is a GABAA receptor PAM, being developed as a potential oral therapy in collaboration with Biogen Inc.
On July 24, 2024, Sage and Biogen announced topline results from the Phase 2 KINETIC 2 study of SAGE-324 as a potential treatment in ET. The KINETIC 2 Study did not demonstrate a statistically significant dose-response relationship in change from baseline to Day 91 based on the primary endpoint, The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Item 4 (upper limb) Total Score, in participants with ET. In addition, there were no statistically significant differences demonstrated for any dose of SAGE-324 versus placebo in the change from baseline to Day 91 on the TETRAS PS Item 4 Total Score or the TETRAS Activities of Daily Living (ADL) Composite Score. Given these results, Sage and Biogen do not plan to conduct further clinical development of SAGE-324 in ET and will close the ongoing open label safety study. The companies are evaluating next steps, if any, for other potential indications.
FINANCIAL RESULTS FOR THE SECOND QUARTER 2024
-
Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2024 were
$647 million $717 million
-
Revenue: Collaboration revenue from sales of ZURZUVAE was
$7.4 million 19% increase compared to the first quarter of 2024. Reported collaboration revenue is50% of the net revenues Biogen records for ZURZUVAE in theU.S. A key factor impacting revenue in the second quarter of 2024 was wholesalers bringing down initial inventory levels. Net revenue from sales of ZULRESSO was$0.6 million $2.5 million
-
R&D Expenses: Research and development expenses were
$62.6 million $6.1 million $97.2 million $4.5 million $3.3 million $22.4 million
-
SG&A Expenses: Selling, general and administrative expenses were
$56.0 million $11.0 million $75.6 million $7.2 million $1.0 million $7.5 million
-
Net Loss: Net loss was
$102.9 million $160.3 million
FINANCIAL GUIDANCE
- Based upon the Company's current operating plan, Sage anticipates that its existing cash, cash equivalents and marketable securities, anticipated funding from ongoing collaborations, and estimated revenues, will support its operations into 2026.
- The Company does not anticipate receipt of any milestone payments from collaborations in the remainder of 2024.
- The Company anticipates operating expenses will decrease in 2024 relative to 2023.
- With the availability of ZURZUVAE as an additional treatment for women with PPD, the Company anticipates ZULRESSO revenues will continue to decrease over time.
Conference Call Information
Sage will host a conference call and webcast today, July 31, 2024, at 4:30 p.m. ET to review its second quarter 2024 financial results and discuss recent corporate updates. The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available on Sage's website following the completion of the event and will be archived for up to 30 days.
About Sage Therapeutics
Sage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company committed to our mission of pioneering solutions to deliver life-changing brain health medicines, so every person can thrive. Sage developed the only two FDA-approved treatments indicated for postpartum depression and is advancing a robust pipeline to target unmet needs in brain health. Sage was founded in 2010 and is headquartered in
Forward-Looking Statements
Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation our statements regarding: our plans, expectations and goals for commercialization of ZURZUVAE as a treatment for women with PPD, including our goal for ZURZUVAE to become the first line treatment and standard of care in this indication; our expectations as to coverage decisions related to ZURZUVAE in PPD and our goal of broad and equitable access to ZURZUVAE for women with PPD who are prescribed treatment; our belief in the commercial potential and profile for ZURZUVAE in the treatment of women with PPD and our expectations as launch progresses; anticipated timelines for reporting of results with respect to ongoing clinical trials of dalzanemdor and other planned activities; plans to evaluate other potential indications for SAGE-324; our belief in the potential profile and benefit of our product candidates; potential indications for our product candidates; the potential for success of our programs, and the opportunity to help patients in various indications; our expectations as to our cash runway, future expense levels and other financial guidance and statements as to the mission and goals for our business. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: our launch and commercialization efforts in the
Financial Tables
| Sage Therapeutics, Inc. and Subsidiaries | |||||
| Condensed Consolidated Balance Sheets | |||||
| (in thousands) | |||||
| (unaudited) | |||||
| June 30, 2024 | December 31, 2023 | ||||
| Cash, cash equivalents and marketable securities | $ |
646,793 |
$ |
753,184 |
|
| Total assets |
|
697,105 |
|
882,277 |
|
| Total liabilities |
|
69,043 |
|
82,747 |
|
| Total stockholders' equity |
|
628,062 |
|
799,530 |
|
| Sage Therapeutics, Inc. and Subsidiaries | |||||||||||||||
| Condensed Consolidated Statements of Operations | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| (unaudited) | |||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
| Product revenue, net | $ |
600 |
|
$ |
2,460 |
|
$ |
2,289 |
|
$ |
5,754 |
|
|||
| Collaboration revenue - related party |
|
7,420 |
|
|
- |
|
|
13,633 |
|
|
- |
|
|||
| Other collaboration revenue |
|
634 |
|
|
14 |
|
|
634 |
|
|
14 |
|
|||
| Total revenues |
|
8,654 |
|
|
2,474 |
|
|
16,556 |
|
|
5,768 |
|
|||
| Operating costs and expenses: | |||||||||||||||
| Cost of revenues |
|
1,407 |
|
|
205 |
|
|
2,676 |
|
|
435 |
|
|||
| Research and development |
|
62,564 |
|
|
97,161 |
|
|
134,297 |
|
|
189,987 |
|
|||
| Selling, general and administrative |
|
55,983 |
|
|
75,565 |
|
|
108,556 |
|
|
141,273 |
|
|||
| Total operating costs and expenses |
|
119,954 |
|
|
172,931 |
|
|
245,529 |
|
|
331,695 |
|
|||
| Loss from operations |
|
(111,300 |
) |
|
(170,457 |
) |
|
(228,973 |
) |
|
(325,927 |
) |
|||
| Interest income, net |
|
8,431 |
|
|
10,173 |
|
|
17,634 |
|
|
19,003 |
|
|||
| Other income (expense), net |
|
15 |
|
|
(41 |
) |
|
2 |
|
|
(229 |
) |
|||
| Net loss | $ |
(102,854 |
) |
$ |
(160,325 |
) |
$ |
(211,337 |
) |
$ |
(307,153 |
) |
|||
| Net loss per share - basic and diluted | $ |
(1.70 |
) |
$ |
(2.68 |
) |
$ |
(3.50 |
) |
$ |
(5.14 |
) |
|||
| Weighted average shares outstanding - basic and diluted |
|
60,538,319 |
|
|
59,769,640 |
|
|
60,337,258 |
|
|
59,722,147 |
|
|||
SELECT IMPORTANT SAFETY INFORMATION FOR ZURZUVAE
ZURZUVAE (zuranolone) CIV, is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression in adults.
This does not include all the information needed to use ZURZUVAE safely and effectively. See full prescribing information for ZURZUVAE.
ZURZUVAE may cause serious side effects, including decreased awareness and alertness, which can affect your ability to drive safely or safely do other dangerous activities. Do not drive, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose. You may not be able to tell on your own if you can drive safely or tell how much ZURZUVAE is affecting you. ZURZUVAE may cause central nervous system (CNS) depressant effects including sleepiness, drowsiness, slow thinking, dizziness, confusion, and trouble walking. Taking alcohol, other medicines that cause CNS depressant effects such as benzodiazepines, or opioids while taking ZURZUVAE can make these symptoms worse and may also cause trouble breathing. ZURZUVAE is a federally controlled substance schedule IV because it contains zuranolone, which can be abused or lead to dependence. Tell your healthcare provider right away if you become pregnant or plan to become pregnant during treatment with ZURZUVAE. You should use effective birth control (contraception) during treatment with ZURZUVAE and for 1 week after the final dose. ZURZUVAE and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger. ZURZUVAE is not for use in children. The most common side effects of ZURZUVAE include sleepiness or drowsiness, dizziness, common cold, diarrhea, feeling tired, weak, or having no energy, and urinary tract infection.
SELECT IMPORTANT SAFETY INFORMATION for ZULRESSO
ZULRESSO (brexanolone) CIV, is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression in individuals 15 years and older.
This does not include all the information needed to use ZULRESSO safely and effectively. See full prescribing information for ZULRESSO.
WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS
See full prescribing information for complete boxed warning
Patients are at risk of excessive sedation or sudden loss of consciousness during administration of ZULRESSO.
Because of the risk of serious harm, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren).
ZULRESSO is available only through a restricted program called the ZULRESSO REMS.
WARNINGS AND PRECAUTIONS
Suicidal Thoughts and Behaviors: Consider changing the therapeutic regimen, including discontinuing ZULRESSO, in patients whose PPD becomes worse or who experience emergent suicidal thoughts and behavior.
ADVERSE REACTIONS: Most common adverse reactions (incidence ≥
USE IN SPECIFIC POPULATIONS
- Pregnancy: ZULRESSO may cause fetal harm. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/
- Renal Impairment: Avoid use of ZULRESSO in patients with end stage renal disease (ESRD)
To report SUSPECTED ADVERSE REACTIONS, contact Sage Therapeutics, Inc. at 1-844-4-SAGERX (1-844-472-4379) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see accompanying full Prescribing Information including Boxed Warning.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240731771837/en/
Investor Contact
Ashley Kaplowitz
786-252-1419
ashley.kaplowitz@sagerx.com
Media Contact
Francesca Dellelci
856.261.5975
francesca.dellelci@sagerx.com
Source: Sage Therapeutics, Inc.
FAQ
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