SPRAVATO® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression
Johnson & Johnson (NYSE: JNJ) announced FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression. The approval follows FDA Priority Review and is based on clinical data showing superior improvement in depressive symptoms compared to placebo as early as 24 hours.
Key findings show that at week 4, 22.5% of SPRAVATO® patients achieved remission compared to 7.6% for placebo. The treatment demonstrated improvements across all 10 MADRS (Montgomery-Asberg Depression Rating Scale) items at day 28. The safety profile remained consistent with existing clinical data, with no new concerns identified.
This breakthrough addresses a significant medical need, as approximately one-third of the estimated 21 million U.S. adults with major depressive disorder (MDD) do not respond to oral antidepressants alone. SPRAVATO® has been administered to over 140,000 patients worldwide and is available through a restricted REMS Program due to potential risks.
Johnson & Johnson (NYSE: JNJ) ha annunciato l'approvazione da parte della FDA di SPRAVATO® (esketamina) come prima e unica monoterapia per adulti con depressione resistente al trattamento. L'approvazione è stata ottenuta dopo una valutazione prioritaria da parte della FDA ed è basata su dati clinici che mostrano un miglioramento superiore nei sintomi depressivi rispetto al placebo già 24 ore dopo.
I risultati chiave mostrano che alla settimana 4, il 22,5% dei pazienti trattati con SPRAVATO® ha raggiunto la remissione rispetto al 7,6% del gruppo placebo. Il trattamento ha dimostrato miglioramenti in tutti i 10 elementi della MADRS (Montgomery-Asberg Depression Rating Scale) al giorno 28. Il profilo di sicurezza è rimasto coerente con i dati clinici esistenti, senza nuove preoccupazioni identificate.
Questa innovazione risponde a un bisogno medico significativo, poiché circa un terzo degli oltre 21 milioni di adulti statunitensi con disturbo depressivo maggiore (MDD) non risponde esclusivamente agli antidepressivi orali. SPRAVATO® è stato somministrato a oltre 140.000 pazienti in tutto il mondo ed è disponibile attraverso un Programma REMS ristretto a causa dei potenziali rischi.
Johnson & Johnson (NYSE: JNJ) anunció la aprobación de la FDA de SPRAVATO® (esketamina) como la primera y única monoterapia para adultos con depresión resistente al tratamiento. La aprobación siguió a la Revisión Prioritaria de la FDA y se basa en datos clínicos que muestran una mejora superior en los síntomas depresivos en comparación con el placebo a partir de las 24 horas.
Los hallazgos clave muestran que en la semana 4, el 22.5% de los pacientes tratados con SPRAVATO® alcanzaron remisión en comparación con el 7.6% del placebo. El tratamiento demostró mejoras en los 10 ítems de la MADRS (Escala de Calificación de Depresión de Montgomery-Asberg) al día 28. El perfil de seguridad se mantuvo consistente con los datos clínicos existentes, sin nuevas preocupaciones identificadas.
Este avance atiende una necesidad médica significativa, ya que aproximadamente un tercio de los 21 millones de adultos en EE. UU. con trastorno depresivo mayor (MDD) no responde solo a los antidepresivos orales. SPRAVATO® ha sido administrado a más de 140,000 pacientes en todo el mundo y está disponible a través de un Programa REMS restringido debido a riesgos potenciales.
존슨 앤드 존슨 (NYSE: JNJ)은 치료 저항성 우울증이 있는 성인 대상의 첫 번째이자 유일한 단독 요법으로 SPRAVATO® (에스케타민)가 FDA 승인을 받았다고 발표했습니다. 이번 승인은 FDA의 우선 심사를 통과했으며, 임상 데이터에 기반하여 24시간 이내에 위약 대비 우울증 증상이 더 향상되었음을 보여줍니다.
주요 결과에 따르면, 4주차에 SPRAVATO®를 투여받은 환자의 22.5%가 관해에 도달했습니다 반면 위약군에서는 7.6%였습니다. 치료는 28일째에 MADRS (Montgomery-Asberg Depression Rating Scale)의 모든 10개 항목에서 개선을 보여주었습니다. 안전성 프로필은 기존 임상 데이터와 일치하여 새로운 우려 사항은 발견되지 않았습니다.
이 돌파구는 약 2100만 명의 미국 성인 중 우울증이 심각한 장애인(MDD) 중 3분의 1이 경구 항우울제에만 반응하지 않는다는 점에서 중요한 의료 욕구를 충족합니다. SPRAVATO®는 전 세계 14만 명 이상의 환자에게 투여되었으며 잠재적 위험으로 인해 제한된 REMS 프로그램을 통해 제공됩니다.
Johnson & Johnson (NYSE: JNJ) a annoncé l'approbation par la FDA de SPRAVATO® (eskétamine) en tant que première et unique monothérapie pour les adultes atteints de dépression résistante au traitement. Cette approbation fait suite à un examen prioritaire de la FDA et repose sur des données cliniques montrant une amélioration supérieure des symptômes dépressifs par rapport au placebo dès 24 heures.
Les principaux résultats montrent qu'à la semaine 4, 22,5 % des patients traités par SPRAVATO® ont atteint la rémission contre 7,6 % pour le placebo. Le traitement a montré des améliorations dans tous les 10 éléments de la MADRS (Montgomery-Asberg Depression Rating Scale) au jour 28. Le profil d'innocuité est resté cohérent avec les données cliniques existantes, sans nouvelles préoccupations identifiées.
Cette avancée répond à un besoin médical significatif, car environ un tiers des 21 millions d'adultes américains estimés souffrant de trouble dépressif majeur (MDD) ne réagissent pas uniquement aux antidépresseurs oraux. SPRAVATO® a été administré à plus de 140 000 patients dans le monde et est disponible par le biais d'un programme REMS restreint en raison de risques potentiels.
Johnson & Johnson (NYSE: JNJ) hat die FDA-Zulassung für SPRAVATO® (Esketamin) als die erste und einzige Monotherapie für Erwachsene mit behandlungsresistenter Depression bekannt gegeben. Diese Zulassung folgt einer Prioritätsprüfung der FDA und basiert auf klinischen Daten, die zeigen, dass es bereits nach 24 Stunden eine überlegene Verbesserung der depressiven Symptome im Vergleich zu Placebo gab.
Wichtige Ergebnisse zeigen, dass in Woche 4 22,5% der SPRAVATO®-Patienten eine Remission erreichten im Vergleich zu 7,6% bei Placebo. Die Behandlung zeigte Verbesserungen in allen 10 ITEMs der MADRS (Montgomery-Asberg Depression Rating Scale) am Tag 28. Das Sicherheitsprofil blieb konsistent mit bestehenden klinischen Daten, ohne neue Bedenken.
Dieser Durchbruch adressiert einen signifikanten medizinischen Bedarf, da etwa ein Drittel der geschätzten 21 Millionen amerikanischen Erwachsenen mit schwerer depressiver Störung (MDD) nicht auf orale Antidepressiva allein anspricht. SPRAVATO® wurde bereits über 140.000 Patienten weltweit verabreicht und ist aufgrund potenzieller Risiken über ein eingeschränktes REMS-Programm verfügbar.
- First FDA-approved monotherapy for treatment-resistant depression
- Superior efficacy vs placebo (22.5% vs 7.6% remission rate at week 4)
- Rapid onset of action (improvement as early as 24 hours)
- Established safety profile with no new concerns
- Large patient base with over 140,000 treated worldwide
- Requires restricted REMS Program due to serious adverse outcome risks
- Potential risks include sedation, dissociation, respiratory depression, abuse, and misuse
Insights
The FDA approval of SPRAVATO® as monotherapy for treatment-resistant depression represents a major therapeutic advancement. The clinical data shows impressive efficacy with 22.5% of patients achieving remission at 4 weeks compared to 7.6% for placebo. The rapid onset of action within 24 hours addresses a critical unmet need in depression treatment.
The market opportunity is substantial, with 21 million adults in the U.S. affected by major depressive disorder. Approximately one-third of these patients don't respond to conventional antidepressants, creating a significant addressable market for SPRAVATO®. The real-world evidence from 140,000 treated patients globally validates both safety and efficacy.
This approval strengthens JNJ's competitive position in the $16 billion antidepressant market. As the first approved monotherapy for treatment-resistant depression, SPRAVATO® has significant revenue growth potential. The removal of the requirement for concurrent oral antidepressants expands the eligible patient population and simplifies treatment protocols.
The Priority Review designation and strong efficacy data support premium pricing potential. With depression-related economic burden heavily weighted toward treatment-resistant cases, insurers have incentive to cover an effective monotherapy option. Based on current pricing and the expanded indication, this could generate additional annual revenue of $1-2 billion at peak sales.
This approval addresses key market barriers that SPRAVATO®'s initial adoption. The monotherapy indication provides physicians greater prescribing flexibility and eliminates compliance challenges associated with daily oral medications. The robust safety database from 6 years of real-world use should increase physician comfort with prescribing.
The competitive landscape remains favorable as no other rapid-acting antidepressants are approved as monotherapy for treatment-resistant depression. The glutamate-targeting mechanism provides a unique value proposition. With 140,000 patients treated globally, SPRAVATO® has established strong brand recognition and distribution infrastructure through its REMS program.
Following
SPRAVATO® alone showed a rapid and superior improvement vs. placebo in the Montgomery-Asberg Depression Rating Scale (MADRS) total score, with numerical improvements across all 10 MADRS items seen at day 28 in a post-hoc analysis2
Monotherapy data adds to well-established clinical efficacy and real-world safety profile of SPRAVATO®
MDD is one of the most common psychiatric disorders, with an estimated 21 million adults in the
"Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, healthcare providers have had few options to offer patients much-needed symptom improvement," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "SPRAVATO® is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the need for daily oral antidepressants."
This approval, which was granted following FDA Priority Review, is supported by positive results from the randomized, double-blind, multicenter, placebo-controlled study in which SPRAVATO® alone showed a rapid and superior improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score vs. placebo. In a post-hoc analysis, SPRAVATO® demonstrated numerical improvements across all 10 MADRS items at day 28.2 At week 4,
Because of the risks of serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse, and misuse, to facilitate safe and appropriate use, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program.
"For more than six years, I've seen firsthand the real-world impact SPRAVATO® can have on patients' lives," said Gregory Mattingly, M.D., President, Midwest Research Group and Founding Partner, St. Charles Psychiatric Associates. "Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs, so patients can experience the efficacy of SPRAVATO® in as little as 24 hours, through day 28, without the need for a daily oral antidepressant."
SPRAVATO® is unique and works by targeting glutamate, which is the most abundant excitatory neurotransmitter in the brain.6 The mechanism by which esketamine exerts its antidepressant effect is unknown.
Backed by more than a decade of research and almost six years of real-world evidence, SPRAVATO® has proven to be a transformational treatment option for many patients with TRD by reducing depression symptoms in as little as 24 hours and reducing the time to relapse for patients who stay on treatment. To date, SPRAVATO® has been administered to more than 140,000 patients worldwide.
ABOUT TREATMENT-RESISTANT DEPRESSION
Depression is a common mental health disorder that impacts an estimated 280 million people worldwide.3 In the
ABOUT SPRAVATO®
SPRAVATO® (esketamine) CIII nasal spray is approved by the
IMPORTANT SAFETY INFORMATION
What is SPRAVATO® (esketamine) CIII nasal spray?
SPRAVATO® is a prescription medicine used:
- with or without an antidepressant taken by mouth, to treat adults with treatment-resistant depression (TRD)
- with an antidepressant taken by mouth, to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.
It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.
It is not known if SPRAVATO® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®? | ||||
SPRAVATO® can cause serious side effects, including: | ||||
• Sedation, dissociation, and respiratory depression. SPRAVATO® may cause | ||||
• Tell your healthcare provider right away if you feel like you cannot stay | ||||
• Your healthcare provider must monitor you for serious side effects for at | ||||
• Abuse and misuse. There is a risk for abuse and misuse with SPRAVATO®, | ||||
• Tell your healthcare provider if you have ever abused or been dependent | ||||
• Your healthcare provider can tell you more about the differences between | ||||
• SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the | ||||
• Increased risk of suicidal thoughts and actions. Antidepressant medicines | ||||
• Depression and other serious mental illnesses are the most important | ||||
• How can I watch for and try to prevent suicidal thoughts and actions in | ||||
• Pay close attention to any changes, especially sudden changes, in mood, | ||||
• Tell your healthcare provider right away if you have any new or sudden | ||||
• Keep all follow-up visits with your healthcare provider as scheduled. Call | ||||
• Tell your healthcare provider or get emergency help right away if you or | ||||
• thoughts about suicide or dying | • suicide attempts | |||
• new or worse depression | • new or worse anxiety | |||
• feeling very agitated or restless | • panic attacks | |||
• trouble sleeping (insomnia) | • new or worse irritability | |||
• acting aggressive, being angry | • acting on dangerous impulses | |||
• an extreme increase in activity | • other unusual changes in | |||
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
- have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called "psychosis" (see, feel, or hear things that are not there, or believe in things that are not true).
- are pregnant or plan to become pregnant. SPRAVATO® may harm your unborn baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. SPRAVATO® passes into your breast milk. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See "What is the most important information I should know about SPRAVATO®?"
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
See "What is the most important information I should know about SPRAVATO®?"
Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® include:
• feeling disconnected from yourself, your thoughts, feelings and things around you • dizziness • nausea • feeling sleepy • spinning sensation • decreased feeling of sensitivity (numbness) | • feeling anxious • lack of energy • increased blood pressure • vomiting • feeling drunk • headache • feeling very happy or excited |
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to Johnson & Johnson at 1-800-526-7736, or to the FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider.
cp-170363v4
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at http://www.jnj.com or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Johnson & Johnson International (
CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of SPRAVATO®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products, and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of healthcare products and services; changes to applicable laws and regulations, including global healthcare reforms; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties, and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the
© Johnson & Johnson and its affiliates 2025. All rights reserved.
1. | Janik A, Qiu X, Lane R, et al. SPRAVATO (esketamine nasal spray) as a monotherapy for treatment-resistant depression (TRD). American Society of Psychopharmacology Annual Meeting.; May 28-31, 2024. Poster W80. |
2. | Data on File. |
3. | World Health Organization. Depressive disorder (depression). Accessed December 2024. who.int/news-room/fact-sheets/detail/depression |
4. | National Institute of Mental Health. Major Depression. National Institute of Mental Health website. Accessed December 2024. nimh.nih.gov/health/statistics/major-depression |
5. | Zhdanava M, Pilon D, Ghelerter I, et al. The prevalence and national burden of treatment-resistant depression and major depressive disorder in |
6. | Cleveland Clinic. Glutamate. Cleveland Clinic website. Accessed December 2024. https://my.clevelandclinic.org/health/articles/22839-glutamate |
7. | Sakurai, H, Suzuki, T, Yoshimura, K, et al. Predicting relapse with individual residual symptoms in major depressive disorder: a reanalysis of the STAR*D data. Psychopharmacology. (2017);234(16): 2453–2461 https://doi.org/10.1007/s00213-017-4634-5. |
Media contact: | Investor contact: |
View original content to download multimedia:https://www.prnewswire.com/news-releases/spravato-esketamine-approved-in-the-us-as-the-first-and-only-monotherapy-for-adults-with-treatment-resistant-depression-302355833.html
SOURCE Johnson & Johnson
FAQ
What is the new FDA approval for JNJ's SPRAVATO in January 2025?
How effective is SPRAVATO as a standalone treatment based on clinical trials?
What are the main risks associated with JNJ's SPRAVATO treatment?
How many patients have been treated with SPRAVATO worldwide?
What is the market potential for SPRAVATO given the MDD patient population?
