PharmaTher Provides Update on FDA New Drug Application for Ketamine
PharmaTher Holdings (OTCQB: PHRRF) announced plans to resubmit information to the FDA by end-February 2025, addressing minor deficiencies outlined in the Complete Response Letter (CRL) from October 22, 2024. The company expects FDA approval for ketamine in Q2-2025.
The FDA's requests focus on drug substance, product, manufacturing, and microbiology information. Notably, the FDA expressed no concerns about the ketamine submission batches' stability, which achieved 18 months without issues. No additional preclinical or clinical studies were requested.
Ketamine, an essential medicine used for anesthesia and pain relief in hospitals, is also administered for various mental health, neurological, and pain disorders outside FDA and Health Canada approved indications.
PharmaTher Holdings (OTCQB: PHRRF) ha annunciato piani per ripresentare informazioni alla FDA entro la fine di febbraio 2025, affrontando piccole carenze delineate nella Lettera di Risposta Completa (CRL) del 22 ottobre 2024. L'azienda prevede l'approvazione della FDA per la ketamina nel secondo trimestre del 2025.
Le richieste della FDA si concentrano su informazioni riguardanti la sostanza attiva, il prodotto, la produzione e la microbiologia. È importante notare che la FDA non ha espresso preoccupazioni riguardo alla stabilità dei lotti di ketamina presentati, che hanno raggiunto 18 mesi senza problemi. Non sono stati richiesti ulteriori studi preclinici o clinici.
La ketamina, un medicinale essenziale utilizzato per l'anestesia e il sollievo dal dolore negli ospedali, è anche somministrata per vari disturbi di salute mentale, neurologici e del dolore al di fuori delle indicazioni approvate dalla FDA e da Health Canada.
PharmaTher Holdings (OTCQB: PHRRF) anunció planes para volver a presentar información a la FDA a finales de febrero de 2025, abordando deficiencias menores señaladas en la Carta de Respuesta Completa (CRL) del 22 de octubre de 2024. La compañía espera la aprobación de la FDA para la ketamina en el segundo trimestre de 2025.
Las solicitudes de la FDA se centran en la sustancia activa, el producto, la fabricación y la información microbiológica. Es notable que la FDA no expresó preocupaciones sobre la estabilidad de los lotes de ketamina presentados, que alcanzaron 18 meses sin problemas. No se solicitaron estudios preclínicos o clínicos adicionales.
La ketamina, un medicamento esencial utilizado para la anestesia y el alivio del dolor en hospitales, también se administra para diversos trastornos de salud mental, neurológicos y del dolor fuera de las indicaciones aprobadas por la FDA y Health Canada.
PharmaTher Holdings (OTCQB: PHRRF)는 2025년 2월 말까지 FDA에 정보를 재제출할 계획을 발표했으며, 이는 2024년 10월 22일자 완전 응답 서한(CRL)에서 언급된 경미한 결함을 다루고 있습니다. 회사는 2025년 2분기에 케타민에 대한 FDA 승인을 예상하고 있습니다.
FDA의 요청은 약물 성분, 제품, 제조 및 미생물학 정보에 중점을 두고 있습니다. 특히, FDA는 케타민 제출 배치의 안정성에 대해 우려를 표명하지 않았으며, 이는 문제 없이 18개월을 달성했습니다. 추가적인 전임상 또는 임상 연구는 요청되지 않았습니다.
케타민은 병원에서 마취 및 통증 완화를 위해 사용되는 필수 의약품으로, FDA 및 Health Canada에서 승인된 적응증 외에도 다양한 정신 건강, 신경학 및 통증 장애에 대해 투여됩니다.
PharmaTher Holdings (OTCQB: PHRRF) a annoncé des projets de soumettre à nouveau des informations à la FDA d'ici fin février 2025, en répondant à des déficiences mineures décrites dans la Lettre de Réponse Complète (CRL) du 22 octobre 2024. La société s'attend à une approbation de la FDA pour la kétamine au deuxième trimestre 2025.
Les demandes de la FDA portent sur des informations concernant la substance médicamenteuse, le produit, la fabrication et la microbiologie. Il est à noter que la FDA n'a exprimé aucune préoccupation concernant la stabilité des lots de kétamine soumis, qui ont atteint 18 mois sans problèmes. Aucune étude préclinique ou clinique supplémentaire n'a été demandée.
La kétamine, un médicament essentiel utilisé pour l'anesthésie et le soulagement de la douleur dans les hôpitaux, est également administrée pour divers troubles de la santé mentale, neurologiques et de la douleur en dehors des indications approuvées par la FDA et Santé Canada.
PharmaTher Holdings (OTCQB: PHRRF) hat Pläne angekündigt, bis Ende Februar 2025 Informationen erneut bei der FDA einzureichen, um geringfügige Mängel zu beheben, die im vollständigen Antwortschreiben (CRL) vom 22. Oktober 2024 skizziert wurden. Das Unternehmen erwartet die FDA-Zulassung für Ketamin im 2. Quartal 2025.
Die Anforderungen der FDA konzentrieren sich auf Informationen zu Wirkstoff, Produkt, Herstellung und Mikrobiologie. Bemerkenswert ist, dass die FDA keine Bedenken hinsichtlich der Stabilität der eingereichten Ketamin-Batches geäußert hat, die 18 Monate lang ohne Probleme bestanden haben. Es wurden keine zusätzlichen präklinischen oder klinischen Studien angefordert.
Ketamin, ein essentielles Medikament, das in Krankenhäusern für Anästhesie und Schmerztherapie verwendet wird, wird auch bei verschiedenen psychischen, neurologischen und Schmerzstörungen außerhalb der von der FDA und Health Canada genehmigten Indikationen verabreicht.
- FDA classified deficiencies as MINOR, requiring only a minor amendment
- No new preclinical or clinical studies requested by FDA
- Submission batches achieved 18 months stability without issues
- FDA approval timeline projected for Q2-2025
- FDA requires additional information on drug substance, product, manufacturing, and microbiology
- Original submission received Complete Response Letter (CRL) in October 2024
PharmaTher expects to submit the MINOR AMENDMENT to the CRL by end-February 2025 and expects a new approval date for a Q2-2025 FDA approval of ketamine
TORONTO, Feb. 12, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company seeking FDA approval for ketamine, today announced that the Company is on track to resubmit information to the FDA by end-February 2025. This resubmission, which addresses the deficiencies classified as MINOR in the complete response letter (“CRL”) provided by the FDA dated October 22, 2024, is a significant step towards obtaining FDA approval. The Company expects to receive a new approval date for a Q2-2025 FDA approval.
As noted by the FDA in the CRL, the resubmission to this CRL will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR. 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.
PharmaTher is fully committed to the potential of ketamine and is dedicated to its development and approval.
With pending FDA approval for ketamine on the horizon, the Company remains focused on its mission to be a leading innovator and provider of ketamine to treat unmet medical needs. It is well-known that ketamine is an essential medicine used for anesthesia and analgesia (pain relief) and has been used 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. The potential of ketamine to make a significant impact on patient lives is immense. PharmaTher, with its innovative approaches and commitment to patient care, is poised to play a pivotal role in making ketamine available to millions of people globally.
PharmaTher is committed to keeping stakeholders informed and will continue to provide updates as they occur.
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. Learn more at PharmaTher.com.
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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