Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression
Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA seeking approval of SPRAVATO® (esketamine) as a monotherapy for adults with treatment-resistant depression (TRD). This submission is based on positive results from the Phase 4 TRD4005 study, which showed rapid improvement in depressive symptoms as early as 24 hours after the first dose, sustained through at least 4 weeks of treatment. The safety profile was consistent with existing clinical data.
SPRAVATO® is currently approved in combination with an oral antidepressant for TRD and depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. It has been approved in 77 countries and administered to over 100,000 people worldwide. This new application aims to expand its use as a standalone treatment for TRD, potentially offering a new option for patients who have not responded adequately to multiple oral antidepressants.
Johnson & Johnson ha presentato una domanda supplementare per un nuovo farmaco (sNDA) alla FDA degli Stati Uniti per ottenere l'approvazione di SPRAVATO® (esketamina) come monoterapia per adulti con depressione resistente al trattamento (TRD). Questa presentazione si basa su risultati positivi dello studio di Fase 4 TRD4005, che ha mostrato un rapido miglioramento dei sintomi depressivi già 24 ore dopo la prima dose, mantenuto per almeno 4 settimane di trattamento. Il profilo di sicurezza è stato coerente con i dati clinici esistenti.
SPRAVATO® è attualmente approvato in combinazione con un antidepressivo orale per TRD e sintomi depressivi in adulti con disturbo depressivo maggiore (MDD) con ideazione o comportamento suicida acuto. È stato approvato in 77 paesi e somministrato a oltre 100.000 persone in tutto il mondo. Questa nuova domanda mira a espandere il suo utilizzo come trattamento autonomo per TRD, offrendo potenzialmente una nuova opzione per i pazienti che non hanno risposto adeguatamente a molteplici antidepressivi orali.
Johnson & Johnson ha presentado una solicitud suplementaria de nuevo medicamento (sNDA) a la FDA de EE. UU. buscando la aprobación de SPRAVATO® (esketamina) como monoterapia para adultos con depresión resistente al tratamiento (TRD). Esta solicitud se basa en resultados positivos del estudio de Fase 4 TRD4005, que mostró una mejora rápida en los síntomas depresivos tan pronto como 24 horas después de la primera dosis, mantenida durante al menos 4 semanas de tratamiento. El perfil de seguridad fue consistente con los datos clínicos existentes.
SPRAVATO® está actualmente aprobado en combinación con un antidepresivo oral para TRD y síntomas depresivos en adultos con trastorno depresivo mayor (MDD) con ideación o comportamiento suicida agudo. Ha sido aprobado en 77 países y administrado a más de 100,000 personas en todo el mundo. Esta nueva solicitud tiene como objetivo ampliar su uso como tratamiento independiente para TRD, ofreciendo potencialmente una nueva opción para los pacientes que no han respondido adecuadamente a múltiples antidepresivos orales.
존슨앤드존슨은 SPRAVATO® (에스케타민)의 치료 저항성 우울증 (TRD) 성인을 위한 단독 요법 승인을 요청하는 보충 신약 신청서(sNDA)를 미국 FDA에 제출했습니다. 이 제출은 4상 TRD4005 연구에서 얻은 긍정적인 결과에 기반하고 있으며, 첫 투여 후 24시간 이내에 우울증 증상이 빠르게 개선되었고, 최소 4주간 지속되었습니다. 안전성 프로필은 기존 임상 데이터와 일치했습니다.
현재 SPRAVATO®는 급성 자살 사고나 행동을 동반한 주요 우울 장애 (MDD) 성인의 TRD 및 우울증 증상에 대한 경구 항우울제와 함께 사용 승인되었습니다. 현재 77개국에서 승인되었으며, 전 세계에서 100,000명 이상의 사람들이 치료를 받았습니다. 이번 신규 신청은 TRD에 대한 독립적인 치료로서의 사용을 확대하는 것을 목표로 하며, 여러 경구 항우울제에 충분히 반응하지 않은 환자에게 새로운 옵션을 제공할 수 있습니다.
Johnson & Johnson a soumis une demande complémentaire de nouveau médicament (sNDA) à la FDA américaine pour obtenir l'approbation de SPRAVATO® (esketamine) comme monothérapie pour les adultes souffrant de dépression résistante au traitement (TRD). Cette soumission est basée sur des résultats positifs de l'étude de Phase 4 TRD4005, qui a montré une amélioration rapide des symptômes dépressifs dès 24 heures après la première dose, maintenue pendant au moins 4 semaines de traitement. Le profil de sécurité était cohérent avec les données cliniques existantes.
SPRAVATO® est actuellement approuvé en association avec un antidépresseur oral pour la TRD et les symptômes dépressifs chez les adultes atteints de trouble dépressif majeur (MDD) avec idéation ou comportement suicidaire aigu. Il a été approuvé dans 77 pays et administré à plus de 100 000 personnes dans le monde. Cette nouvelle demande vise à étendre son utilisation en tant que traitement autonome pour la TRD, offrant potentiellement une nouvelle option aux patients qui n'ont pas répondu de manière adéquate à plusieurs antidépresseurs oraux.
Johnson & Johnson hat einen ergänzenden Antrag auf einen neuen Wirkstoff (sNDA) bei der FDA in den USA eingereicht, um die Genehmigung für SPRAVATO® (Esketamin) als Monotherapie für Erwachsene mit therapierefraktärer Depression (TRD) zu beantragen. Dieser Antrag basiert auf positiven Ergebnissen der Phase-4-Studie TRD4005, die bereits 24 Stunden nach der ersten Dosis eine schnelle Verbesserung der depressiven Symptome zeigte, die über mindestens 4 Wochen der Behandlung aufrechterhalten wurde. Das Sicherheitsprofil entsprach den bestehenden klinischen Daten.
SPRAVATO® ist derzeit in Kombination mit einem oralen Antidepressivum für TRD und depressive Symptome bei Erwachsenen mit schwerer depressiver Störung (MDD) mit akuter Suizididee oder -verhalten zugelassen. Es wurde in 77 Ländern zugelassen und mehr als 100.000 Menschen weltweit behandelt. Dieser neue Antrag zielt darauf ab, die Anwendung als eigenständige Behandlung für TRD zu erweitern, um möglicherweise eine neue Option für Patienten zu bieten, die auf mehrere orale Antidepressiva nicht adeequat reagiert haben.
- Potential expansion of SPRAVATO® as a monotherapy for TRD, offering a new treatment option
- Rapid improvement in depressive symptoms observed within 24 hours of first dose
- Sustained efficacy through at least 4 weeks of treatment
- Consistent safety profile with existing clinical data
- SPRAVATO® already approved in 77 countries and used by over 100,000 people worldwide
- Potential for serious side effects including sedation, dissociation, and respiratory depression
- Risk of abuse and physical and psychological dependence
- Restricted availability through SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program
- Increased risk of suicidal thoughts and actions in some patients
Phase 4 SPRAVATO® monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at least 4 weeks
Monotherapy submission builds on more than a decade of research, 31 clinical trials and more than five years of real-world use that reinforce the safety and efficacy of SPRAVATO®
"Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don't effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones," said Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "We're pleased to build on the more than a decade of research reinforcing the safety and efficacy of SPRAVATO® and look forward to working with the FDA to bring this innovative treatment to patients as a monotherapy option."
The submission is supported by positive results from the Phase 4 TRD4005 study that evaluated the efficacy, safety and tolerability of SPRAVATO® administered as a monotherapy. The randomized, double-blind, multicenter, placebo-controlled study showed a rapid change in Montgomery-Asberg Depression Rating Scale (MADRS) total score as early as 24 hours after the first SPRAVATO® dose and sustained through at least 4 weeks of treatment. The safety profile of SPRAVATO® monotherapy was consistent with the existing body of clinical data in combination with an oral antidepressant, and no new safety concerns were identified.2
SPRAVATO® is approved by the FDA, in combination with an oral antidepressant, to treat adults with TRD and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. To date, SPRAVATO® has been approved in 77 countries and administered to more than 100,000 people worldwide.
IMPORTANT SAFETY INFORMATION
What is SPRAVATO® (esketamine) CIII nasal spray?
SPRAVATO® is a prescription medicine, used along with an antidepressant taken by mouth to treat:
- Adults with treatment-resistant depression (TRD)
- 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:
o Your healthcare provider must monitor you for serious side effects for at least 2 hours (including pulse oximetry) after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
|
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 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. 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® when used along with an antidepressant taken by mouth 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 • 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 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-170363v3
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 where 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.janssen.com/johnson-johnson-innovative-medicine. Follow us at @JNJInnovMed.
Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies.
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 2024. All rights reserved.
Media contact:
Caitlin Lormel
Johnson & Johnson
clormel@its.jnj.com
732 740 1701
Investor contact:
Raychel Kruper
Johnson & Johnson
investor-relations@its.jnj.com
- Zhdanava M, Pilon D, Ghelerter I, et al. The prevalence and national burden of treatment-resistant depression and major depressive disorder in
the United States . J Clin Psychiatry. 2021;82(2):20m13699. - A. Janik, X. Qiu, R. Lane, V. Popova, W.C. Drevets, C. Canuso, D.J. Fu. SPRAVATO (Esketamine Nasal Spray) as a Monotherapy for Treatment-resistant Depression (TRD). American Society of Psychopharmacology Annual Meeting.; May 28-31, 2024. Poster W80.
View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnson-seeks-us-fda-approval-of-spravato-esketamine-as-the-first-and-only-monotherapy-for-adults-with-treatment-resistant-depression-302201474.html
SOURCE Johnson & Johnson
FAQ
What is Johnson & Johnson (JNJ) seeking FDA approval for regarding SPRAVATO®?
What were the key findings from the Phase 4 study of SPRAVATO® (JNJ) as a monotherapy?
How many countries have approved SPRAVATO® (JNJ) and how many patients have used it?