PharmaTher Provides Complete Response Amendment for US FDA New Drug Application for Ketamine
PharmaTher Holdings (PHRRF) has submitted its complete response amendment to the FDA for its Ketamine new drug application, addressing minor deficiencies outlined in the October 2024 complete response letter. The company expects FDA approval in Q2-2025.
The FDA's requests focused on drug substance, product, manufacturing, and microbiology information. Notably, no new preclinical or clinical studies were required, and there were no concerns about the stability of Ketamine submission batches.
The company aims to address the U.S. Ketamine shortage, which has persisted since February 2018. This shortage has led to increased availability of compounded Ketamine products, prompting FDA concerns about risks associated with compounded versions, particularly in telehealth settings.
Ketamine, listed on the WHO Essential Medicines List, is primarily used for anesthesia and pain relief in hospitals. A peer-reviewed study has shown significant patient improvement for depression, anxiety, and suicidal ideation with Ketamine intravenous therapy.
PharmaTher Holdings (PHRRF) ha presentato la sua risposta completa all'emendamento alla FDA per la nuova applicazione del farmaco Ketamina, affrontando le piccole carenze evidenziate nella lettera di risposta completa di ottobre 2024. L'azienda prevede l'approvazione della FDA nel Q2-2025.
Le richieste della FDA si sono concentrate su informazioni relative alla sostanza del farmaco, al prodotto, alla produzione e alla microbiologia. È importante notare che non sono stati richiesti nuovi studi preclinici o clinici e non ci sono state preoccupazioni riguardo alla stabilità dei lotti di Ketamina presentati.
L'azienda mira a risolvere la carenza di Ketamina negli Stati Uniti, che persiste dal febbraio 2018. Questa carenza ha portato a una maggiore disponibilità di prodotti di Ketamina composti, suscitando preoccupazioni da parte della FDA sui rischi associati alle versioni composte, in particolare nei contesti di telemedicina.
La Ketamina, inclusa nell'elenco dei farmaci essenziali dell'OMS, è principalmente utilizzata per l'anestesia e il sollievo dal dolore negli ospedali. Uno studio sottoposto a revisione paritaria ha mostrato un significativo miglioramento nei pazienti affetti da depressione, ansia e ideazione suicidaria con la terapia endovenosa di Ketamina.
PharmaTher Holdings (PHRRF) ha presentado su respuesta completa enmendada a la FDA para la nueva solicitud de medicamento de Ketamina, abordando deficiencias menores señaladas en la carta de respuesta completa de octubre de 2024. La compañía espera la aprobación de la FDA en Q2-2025.
Las solicitudes de la FDA se centraron en información sobre la sustancia del medicamento, el producto, la fabricación y la microbiología. Es notable que no se requerían nuevos estudios preclínicos o clínicos, y no hubo preocupaciones sobre la estabilidad de los lotes de Ketamina presentados.
La compañía tiene como objetivo abordar la escasez de Ketamina en EE. UU., que ha persistido desde febrero de 2018. Esta escasez ha llevado a una mayor disponibilidad de productos de Ketamina compuestos, lo que ha suscitado preocupaciones por parte de la FDA sobre los riesgos asociados con las versiones compuestas, particularmente en entornos de telemedicina.
La Ketamina, incluida en la Lista de Medicamentos Esenciales de la OMS, se utiliza principalmente para la anestesia y el alivio del dolor en hospitales. Un estudio revisado por pares ha demostrado una mejora significativa en los pacientes con depresión, ansiedad e ideación suicida con la terapia intravenosa de Ketamina.
PharmaTher Holdings (PHRRF)는 2024년 10월의 완전 응답 서한에서 언급된 소소한 결함을 해결하기 위해 케타민 신약 신청서에 대한 FDA에 완전 응답 개정을 제출했습니다. 회사는 2025년 2분기에 FDA 승인을 기대하고 있습니다.
FDA의 요청은 약물 물질, 제품, 제조 및 미생물학 정보에 중점을 두었습니다. 특히, 새로운 전임상 또는 임상 연구가 필요하지 않았으며, 케타민 제출 배치의 안정성에 대한 우려도 없었습니다.
회사는 2018년 2월 이후 지속되고 있는 미국의 케타민 부족 문제를 해결하는 것을 목표로 하고 있습니다. 이 부족으로 인해 복합 케타민 제품의 가용성이 증가했으며, 이는 특히 원격 의료 환경에서 복합 버전과 관련된 위험에 대한 FDA의 우려를 불러일으켰습니다.
케타민은 WHO 필수 의약품 목록에 포함되어 있으며, 주로 병원에서 마취 및 통증 완화를 위해 사용됩니다. 동료 검토된 연구에 따르면 케타민 정맥 요법으로 우울증, 불안 및 자살 사고를 겪는 환자에게 상당한 개선이 나타났습니다.
PharmaTher Holdings (PHRRF) a soumis sa réponse complète modifiée à la FDA pour sa demande de nouveau médicament à base de kétamine, en répondant aux petites lacunes mentionnées dans la lettre de réponse complète d'octobre 2024. La société s'attend à une approbation de la FDA au Q2-2025.
Les demandes de la FDA se sont concentrées sur des informations concernant la substance médicamenteuse, le produit, la fabrication et la microbiologie. Il est à noter qu'aucune nouvelle étude préclinique ou clinique n'était requise et qu'il n'y avait aucune préoccupation concernant la stabilité des lots de kétamine soumis.
La société vise à résoudre la pénurie de kétamine aux États-Unis, qui persiste depuis février 2018. Cette pénurie a conduit à une disponibilité accrue des produits de kétamine composés, suscitant des inquiétudes de la part de la FDA concernant les risques associés aux versions composées, en particulier dans les contextes de télémédecine.
La kétamine, inscrite sur la liste des médicaments essentiels de l'OMS, est principalement utilisée pour l'anesthésie et le soulagement de la douleur dans les hôpitaux. Une étude évaluée par des pairs a montré une amélioration significative des patients souffrant de dépression, d'anxiété et d'idées suicidaires grâce à la thérapie intraveineuse de kétamine.
PharmaTher Holdings (PHRRF) hat seine vollständige Änderungsantwort an die FDA für den neuen Arzneimittelantrag für Ketamin eingereicht, um kleinere Mängel zu beheben, die im vollständigen Antwortschreiben vom Oktober 2024 aufgeführt sind. Das Unternehmen erwartet die Genehmigung der FDA im Q2-2025.
Die Anforderungen der FDA konzentrierten sich auf Informationen über den Arzneistoff, das Produkt, die Herstellung und die Mikrobiologie. Bemerkenswert ist, dass keine neuen präklinischen oder klinischen Studien erforderlich waren und es keine Bedenken hinsichtlich der Stabilität der eingereichten Ketamin-Batches gab.
Das Unternehmen hat sich zum Ziel gesetzt, die Ketamin-Engpässe in den USA anzugehen, die seit Februar 2018 bestehen. Dieser Engpass hat zu einer erhöhten Verfügbarkeit von zusammengesetzten Ketamin-Produkten geführt, was Bedenken der FDA hinsichtlich der Risiken im Zusammenhang mit zusammengesetzten Versionen, insbesondere in Telemedizin-Umgebungen, aufwarf.
Ketamin, das auf der Liste der wesentlichen Arzneimittel der WHO aufgeführt ist, wird hauptsächlich für Anästhesie und Schmerzlinderung in Krankenhäusern eingesetzt. Eine begutachtete Studie hat signifikante Verbesserungen bei Patienten mit Depressionen, Angstzuständen und suizidalen Gedanken durch die intravenöse Therapie mit Ketamin gezeigt.
- FDA approval expected in Q2-2025
- Only minor deficiencies to address in FDA application
- No new clinical trials required
- No stability concerns with submission batches
- Positioned to address ongoing US Ketamine shortage
- FDA approval still pending
- Current product not yet generating revenue
- Faces competition from compounded Ketamine products
Expecting FDA approval of Ketamine in Q2-2025
Solving the shortage problem of Ketamine and unlocking its pharmaceutical potential
Toronto, Ontario--(Newsfile Corp. - March 3, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty pharmaceutical company, is pleased to announce today that the Company has provided its resubmission to the complete response amendment for its U.S. Food and Drug Administration ("FDA") new drug application for Ketamine, which addresses the deficiencies classified as MINOR in the complete response letter ("CRL") provided by the FDA dated October 22, 2024.
Fabio Chianelli, Chairman and CEO of PharmaTher, commented: "I am very pleased that we have addressed all the minor deficiencies detailed in the FDA complete response letter and completed the resubmission response to support our FDA new drug application for Ketamine. This submission is a significant step towards obtaining FDA approval. I look forward to sharing our revised FDA approval goal date, which is expected to be in Q2-2025, with our shareholders and the medical community."
Expecting FDA approval of Ketamine in Q2-2025
PharmaTher has addressed the deficiencies in the CRL and 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 and no new preclinical and clinical studies were requested.
Solving the Ketamine shortage problem in the U.S.
PharmaTher is committed to its overall goal of solving the Ketamine shortage problem in the United States of America and adhering to the FDA's strict manufacturing guidelines. 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. 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.
The outcome with resolving Ketamine's drug shortage issue would be similar to the recent news of Wegovy and Ozempic being removed from the FDA shortage list and compounders have a 60- to 90-day grace period to stop supplying them (see FDA letter).
Unlocking the pharmaceutical potential of Ketamine
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), listed on the WHO Essential Medicines List, 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 pain, neurological, and mental health disorders. A published peer-reviewed study on the real-world effectiveness of Ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation. 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.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of KETARX™ (Ketamine) to fill the unmet medical needs for surgery, 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
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "closer", "could", "confident", "would", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim", "may", "plan", "proposed", "lead", "toward", "anticipate", "provide", and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the three and six months ended November 30, 2024 dated January 21, 2025, which is available on the Company's profile at www.sedarplus.ca.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
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FAQ
When is PharmaTher (PHRRF) expecting FDA approval for its Ketamine drug application?
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