PharmaTher Announces Post Complete Response Letter Clarification Meeting Request Granted from the FDA for Ketamine Abbreviated New Drug Application
PharmaTher Holdings (OTCQB: PHRRF) announced that the FDA granted their request for a post-complete letter clarification meeting following a Complete Response Letter (CRL) received on October 22, 2024, regarding their ketamine Abbreviated New Drug Application. The meeting, initially scheduled for November 29, 2024, is pending rescheduling due to the U.S. Thanksgiving Holiday. The CRL deficiencies are classified as minor, requiring new information related to drug substance, product, manufacturing, and microbiology. No concerns were raised about ketamine stability or need for additional clinical studies. The company aims to address the U.S. ketamine shortage, noting that ketamine has been on the FDA's drug shortage list since February 2018.
PharmaTher Holdings (OTCQB: PHRRF) ha annunciato che la FDA ha approvato la loro richiesta per un incontro di chiarimento post-lettera di risposta completa, dopo aver ricevuto una Complete Response Letter (CRL) il 22 ottobre 2024, riguardante la loro New Drug Application abbreviata per la ketamina. L'incontro, originariamente previsto per il 29 novembre 2024, è in attesa di riprogrammazione a causa della festa del Ringraziamento negli Stati Uniti. Le carenze menzionate nella CRL sono classificate come minori, richiedendo nuove informazioni relative alla sostanza farmacologica, al prodotto, alla produzione e alla microbiologia. Non sono state sollevate preoccupazioni riguardo alla stabilità della ketamina o alla necessità di ulteriori studi clinici. L'azienda ha l'obiettivo di affrontare la carenza di ketamina negli Stati Uniti, notando che la ketamina è stata sulla lista di carenza di farmaci della FDA dal febbraio 2018.
PharmaTher Holdings (OTCQB: PHRRF) anunció que la FDA aprobó su solicitud para una reunión de aclaración posterior a la carta de respuesta completa, tras recibir una Complete Response Letter (CRL) el 22 de octubre de 2024, en relación con su solicitud de nuevo medicamento abreviado para la ketamina. La reunión, inicialmente programada para el 29 de noviembre de 2024, está pendiente de reprogramación debido a las festividades de Acción de Gracias en Estados Unidos. Las deficiencias de la CRL se clasifican como menores, requiriendo nueva información relacionada con la sustancia activa, el producto, la fabricación y la microbiología. No se plantearon preocupaciones sobre la estabilidad de la ketamina o la necesidad de estudios clínicos adicionales. La empresa tiene como objetivo abordar la escasez de ketamina en EE. UU., señalando que la ketamina está en la lista de escasez de medicamentos de la FDA desde febrero de 2018.
PharmaTher Holdings (OTCQB: PHRRF)는 FDA가 2024년 10월 22일에 받은 Complete Response Letter (CRL)와 관련하여 케타민을 위한 약물 승인 요청에 대한 후속 설명 회의 요청을 승인했다고 발표했습니다. 최초 회의는 2024년 11월 29일로 예정되어 있었지만, 미국의 추수감사절 연휴로 인해 재조정이 필요한 상태입니다. CRL의 결함은 경미한 것으로 분류되며, 약물 물질, 제품, 제조 및 미생물학과 관련된 새로운 정보가 필요합니다. 케타민의 안정성이나 추가 임상 연구의 필요성에 대한 우려는 제기되지 않았습니다. 이 회사는 케타민 부족 문제를 해결하는 것을 목표로 하며, 케타민이 2018년 2월부터 FDA의 약물 부족 목록에 올라 있다는 점을 주목하고 있습니다.
PharmaTher Holdings (OTCQB: PHRRF) a annoncé que la FDA avait accepté sa demande de réunion de clarification après la réception d'une Complete Response Letter (CRL) le 22 octobre 2024, concernant sa demande de médicament nouveau abrégé pour la kétamine. La réunion, initialement programmée pour le 29 novembre 2024, est en attente de reprogrammation en raison de la fête de Thanksgiving aux États-Unis. Les lacunes mentionnées dans la CRL sont classées comme mineures, nécessitant de nouvelles informations liées à la substance médicamenteuse, au produit, à la fabrication et à la microbiologie. Aucune préoccupation n'a été soulevée concernant la stabilité de la kétamine ou la nécessité d'études cliniques supplémentaires. L'entreprise vise à remédier à la pénurie de kétamine aux États-Unis, notant que la kétamine est sur la liste des pénuries de médicaments de la FDA depuis février 2018.
PharmaTher Holdings (OTCQB: PHRRF) gab bekannt, dass die FDA ihre Anfrage für ein Treffen zur Klärung nach Erhalt eines Complete Response Letter (CRL) am 22. Oktober 2024 bezüglich ihres ketaminbasierenden Antrags auf ein verkürztes neues Arzneimittel genehmigt hat. Das Treffen, das ursprünglich für den 29. November 2024 angesetzt war, steht aufgrund des amerikanischen Feiertages Thanksgiving noch zur Neuterminierung aus. Die in der CRL aufgeführten Mängel werden als geringfügig eingestuft und erfordern neue Informationen zur Wirkstoffsubstanz, zum Produkt, zur Herstellung und zur Mikrobiologie. Es wurden keine Bedenken hinsichtlich der Stabilität von Ketamin oder dem Bedarf an zusätzlichen klinischen Studien geäußert. Das Unternehmen hat sich zum Ziel gesetzt, den Ketaminmangel in den USA anzugehen und weist darauf hin, dass Ketamin seit Februar 2018 auf der Liste der Arzneimittelknappheit der FDA steht.
- CRL deficiencies classified as minor, indicating less severe regulatory hurdles
- No additional clinical studies required by FDA
- Ketamine submission batches achieved 18 months stability without issues
- Addressing existing market opportunity with ketamine shortage since 2018
- FDA approval delayed due to Complete Response Letter
- Additional information required for drug substance, product, manufacturing, and microbiology
- Meeting delay due to scheduling conflicts
TORONTO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the Company requested a post-complete letter clarification meeting (the “Meeting”) in response to the FDA issuing a complete response letter (CRL), dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024.
On November 12, 2024, the FDA granted the Meeting scheduled for November 29, 2024. Due to the U.S. Thanksgiving Holiday and scheduling conflicts of attendees from its CDMO partner, the Company has requested to reschedule the Meeting for the following week. The Company requested the Meeting to ensure responses to the CRL align with the FDA's requests, leaving nothing to chance. The Company will announce the new Meeting date once it becomes available, propose a timeline for the resubmission to this CRL, and continue to provide updates as they occur.
As announced on October 23, 2024, the deficiencies cited in the CRL are classified as MINOR, and the resubmission to this CRL will be considered a MINOR AMENDMENT. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested.
The Company is committed to its overall goal to solve the ketamine shortage problem in the U.S. and to adhere to the FDA’s strict manufacturing guidelines and FDA-approved prescribing label. Ketamine has been on the FDA’s drug shortage list since February 2018, which is believed to have encouraged the widespread availability of compounded ketamine products not FDA approved for psychiatric disorders. On October 10, 2023, the FDA published a compounding risk alert describing the potential risks associated with compounded ketamine products for psychiatric disorders, specifically from telehealth providers that provide in-home ketamine services. These compounded ketamine products are not FDA approved.
Ketamine is an essential medicine used for anesthesia and analgesia (pain relief) listed on the WHO Essential Medicines List. Health Canada has approved ketamine for use as a sedative and painkiller in hospital settings. Outside of the FDA and Health Canada approved indications, ketamine is also being administered in hospitals and clinics to treat various mental health, neurological and pain disorders. A recently published new peer-reviewed study on the real-world effectiveness of ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of KETARX™ (Ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, neurological, and medical countermeasures indications. PharmaTher owns
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
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FAQ
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