HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Alignment with FDA on Pediatric Study Plan for NRX-100 (ketamine)
NRx Pharmaceuticals (Nasdaq: NRXP) has announced alignment with the FDA on the initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in treating suicidal depression. This alignment is important for the upcoming New Drug Application (NDA) filing, scheduled for Q4 2024. Key points include:
1. FDA recognizes the importance of addressing suicidal depression in adolescents aged 9-17.
2. NRx commits to conducting a clinical trial for NRX-100 in this age group post-adult approval.
3. The company remains on track for NDA filing in Q4 2024, with an anticipated PDUFA date in Q2 2025.
4. Additional neurotoxicity studies in juvenile animals will support safety assessments.
The FDA's feedback highlights the growing crisis of youth suicide in the US, with 10% of high school students attempting suicide in the past year.
NRx Pharmaceuticals (Nasdaq: NRXP) ha annunciato di aver raggiunto un accordo con la FDA sul Piano di Studio Pediatrico Iniziale (iPSP) per NRX-100 (ketamina) nel trattamento della depressione suicidaria. Questo accordo è fondamentale per la futura presentazione della Richiesta di Nuovo Farmaco (NDA), prevista per il quarto trimestre del 2024. I punti chiave includono:
1. La FDA riconosce l'importanza di affrontare la depressione suicidaria negli adolescenti di età compresa tra 9 e 17 anni.
2. NRx si impegna a condurre uno studio clinico per NRX-100 in questo gruppo di età dopo l'approvazione per gli adulti.
3. L'azienda è ancora in programma per la presentazione dell'NDA nel quarto trimestre del 2024, con una data anticipata di PDUFA nel secondo trimestre del 2025.
4. Ulteriori studi di neurotossicità su animali giovani supporteranno le valutazioni di sicurezza.
Il feedback della FDA evidenzia la crescente crisi del suicidio giovanile negli Stati Uniti, con il 10% degli studenti delle scuole superiori che ha tentato il suicidio nell'ultimo anno.
NRx Pharmaceuticals (Nasdaq: NRXP) ha anunciado un acuerdo con la FDA sobre el Plan de Estudio Pediátrico Inicial (iPSP) para NRX-100 (ketamina) en el tratamiento de la depresión suicida. Este acuerdo es importante para la próxima presentación de la Solicitud de Nuevo Medicamento (NDA), programada para el cuarto trimestre de 2024. Los puntos clave incluyen:
1. La FDA reconoce la importancia de abordar la depresión suicida en adolescentes de 9 a 17 años.
2. NRx se compromete a realizar un ensayo clínico para NRX-100 en este grupo de edad después de la aprobación para adultos.
3. La compañía se mantiene en camino para la presentación de la NDA en el cuarto trimestre de 2024, con una fecha de PDUFA anticipada en el segundo trimestre de 2025.
4. Estudios adicionales de neurotoxicidad en animales jóvenes respaldarán las evaluaciones de seguridad.
La retroalimentación de la FDA destaca la creciente crisis del suicidio juvenil en EE. UU., con el 10% de los estudiantes de secundaria que intentaron suicidarse en el último año.
NRx Pharmaceuticals (Nasdaq: NRXP)는 자살 우울증 치료를 위한 NRX-100 (케타민)의 초기 소아 연구 계획(iPSP)에 대해 FDA와 합의했다고 발표했습니다. 이 합의는 2024년 4분기로 예정된 새로운 약물 신청(NDA) 제출에 중요합니다. 주요 내용은 다음과 같습니다:
1. FDA는 9세에서 17세 사이의 청소년에서 자살 우울증을 해결하는 것의 중요성을 인식하고 있습니다.
2. NRx는 성인 승인이 완료된 후 해당 연령대에서 NRX-100에 대한 임상 시험을 실시할 것을 약속합니다.
3. 회사는 2024년 4분기에 NDA 제출을 목표로 하고 있으며, 2025년 2분기에 예상 PDUFA일이 있습니다.
4. 추가적인 청소년 동물에 대한 신경독성 연구는 안전성 평가를 지원할 것입니다.
FDA의 피드백은 미국 청소년 자살 위기의 급증을 강조하고 있으며, 지난 1년간 고등학생의 10%가 자살을 시도했습니다.
NRx Pharmaceuticals (Nasdaq: NRXP) a annoncé un accord avec la FDA concernant le Plan d'Étude Pédiatrique Initial (iPSP) pour NRX-100 (kétyamine) dans le traitement de la dépression suicidaire. Cet accord est crucial pour le dépôt de la Demande de Nouveau Médicament (NDA), prévu pour le quatrième trimestre 2024. Les points clés comprennent:
1. La FDA reconnaît l'importance de traiter la dépression suicidaire chez les adolescents âgés de 9 à 17 ans.
2. NRx s'engage à réaliser un essai clinique pour NRX-100 dans ce groupe d'âge après l'approbation pour les adultes.
3. L'entreprise reste sur la bonne voie pour le dépôt de l'NDA au quatrième trimestre 2024, avec une date PDUFA anticipée au deuxième trimestre 2025.
4. Des études supplémentaires sur la neurotoxicité chez les jeunes animaux soutiendront les évaluations de sécurité.
Les commentaires de la FDA soulignent la crise croissante du suicide chez les jeunes aux États-Unis, 10 % des élèves du secondaire ayant tenté de se suicider au cours de l'année écoulée.
NRx Pharmaceuticals (Nasdaq: NRXP) hat eine Einigung mit der FDA über den anfänglichen pädiatrischen Studienplan (iPSP) für NRX-100 (Ketamin) zur Behandlung von suizidalen Depressionen bekannt gegeben. Diese Einigung ist wichtig für die bevorstehende Einreichung des Antrags auf Zulassung eines neuen Arzneimittels (NDA), die für das 4. Quartal 2024 geplant ist. Wichtige Punkte sind:
1. Die FDA erkennt die Bedeutung der Bekämpfung von suizidalen Depressionen bei Jugendlichen im Alter von 9 bis 17 Jahren an.
2. NRx verpflichtet sich, eine klinische Studie für NRX-100 in dieser Altersgruppe nach Genehmigung bei Erwachsenen durchzuführen.
3. Das Unternehmen ist auf Kurs zur NDA-Einreichung im 4. Quartal 2024, mit einem erwarteten PDUFA-Datum im 2. Quartal 2025.
4. Weitere Neurotoxizitätsstudien an jungen Tieren werden die Sicherheitsbewertungen unterstützen.
Das Feedback der FDA hebt die wachsende Krise der Jugend-Suizide in den USA hervor, wobei 10 % der Schüler in der Oberstufe im vergangenen Jahr einen Suizidversuch unternommen haben.
- Alignment with FDA on Pediatric Study Plan for NRX-100, a important step for NDA filing
- On track for NDA filing in Q4 2024 with anticipated PDUFA date in Q2 2025
- Potential to address a significant unmet medical need in adolescent suicidal depression
- FDA recognition of the urgent need for treatment in the 9-17 age group
- Additional clinical trials required for adolescents aged 9-17, potentially increasing costs and time to market for this demographic
- Need for additional neurotoxicity studies in juvenile animals, which may delay or impact approval for pediatric use
Insights
The FDA's alignment on the initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) marks a significant milestone for HOPE Therapeutics and NRx Pharmaceuticals in their pursuit of a treatment for suicidal depression. This development is particularly noteworthy given the alarming rise in youth suicide rates.
The FDA's recognition of suicide as a serious public health concern among adolescents underscores the urgency of this research. The planned clinical trial for adolescents aged 9-17 could potentially address a critical gap in treatment options for this vulnerable population. However, it's important to note that while ketamine has shown promise in adult populations, its efficacy and safety profile in younger individuals remain to be established.
The commitment to conduct additional neurotoxicity studies in juvenile animal subjects is a important step in ensuring the safety of intravenous ketamine in younger populations. This precautionary measure aligns with standard drug development practices and demonstrates a responsible approach to pediatric drug development.
From a research perspective, the upcoming NDA filing in Q4 2024 and the anticipated PDUFA date in Q2 2025 provide a clear timeline for potential market entry. However, investors should be aware that regulatory approval processes can be unpredictable and timelines may shift.
Overall, this development represents a positive step forward in addressing a critical unmet medical need. However, the true impact of NRX-100 on adolescent suicidal depression will only be determined through rigorous clinical trials and long-term safety monitoring.
The FDA's alignment on the initial Pediatric Study Plan (iPSP) for NRX-100 is a positive development for NRx Pharmaceuticals (NRXP) from a financial perspective. This milestone clears a significant regulatory hurdle and keeps the company on track for its planned New Drug Application (NDA) filing in Q4 2024.
The potential market for a treatment addressing suicidal depression in adolescents is substantial, given the alarming statistics provided by the CDC. With
However, investors should consider several factors:
- Extended Timeline: The requirement for additional clinical trials in adolescents and neurotoxicity studies in juvenile animals may extend the overall development timeline and increase costs.
- Market Expansion: If successful, expanding the indication to include adolescents could significantly broaden the potential market for NRX-100.
- Competitive Landscape: The uniqueness of NRX-100 in addressing suicidal depression, particularly in adolescents, could provide a competitive advantage in the mental health treatment market.
- Regulatory Risks: While the FDA alignment is positive, the approval process remains rigorous and success is not guaranteed.
Financially, NRXP will need to ensure it has sufficient capital to fund these additional studies and support the NDA filing process. The company's ability to meet its projected timelines will be important for maintaining investor confidence and potentially attracting partnership or licensing opportunities.
In conclusion, while this development is promising, investors should closely monitor the company's progress in executing its clinical development plan and meeting regulatory milestones.
- FDA response highlights the importance of addressing suicidal depression in adolescents age 9-17
- Alignment on initial Pediatric Study Plan (iPSP) is a gating requirement for the upcoming filing of an NRX-100 New Drug Application (NDA) for suicidal depression
- NRx remains on track to file the NDA for NRX-100 in Q4 2024 with anticipated PDUFA date in Q2 2025
Suicide is a growing crisis among adolescents in
In support of its upcoming NDA filing, NRx will be submitting existing data supporting the safety and efficacy of ketamine to treat suicidal depression in adults. FDA has now documented its recognition that suicide is a serious and growing public health concern in adolescents as well. Based on the guidance received, NRx and HOPE Therapeutics will commit to conducting a clinical trial of NRX-100 in adolescents aged 9-17 with suicidal depression, but will not be required to study the effects of NRX-100 in younger age groups, following initial approval of NRX-100 in adults. Additional neurotoxicity studies will be conducted in juvenile animal subjects to support the safety of intravenous ketamine in this younger population.
"Youth suicide has reached crisis proportions in
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a care delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
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1 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/Pediatric-Study-Plans--Content-of-and-Process-for-Submitting-Initial-Pediatric-Study-Plans-and-Amended-Pediatric-Study-Plans.pdf
2 https://www.cdc.gov/healthyyouth/data/yrbs/pdf/YRBS_Data-Summary-Trends_Report2023_508.pdf
3 https://www.apa.org/monitor/2023/07/psychologists-preventing-teen-suicide
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SOURCE NRx Pharmaceuticals, Inc.
FAQ
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