PharmaTher Receives US FDA Approval Goal Date for Ketamine
PharmaTher Holdings (OTCQB: PHRRF) has received an Amendment Acknowledgement Letter from the FDA for its Ketamine New Drug Application, with an approval goal date of June 4, 2025. The FDA classified this as a minor amendment qualifying for priority review.
The company previously addressed deficiencies from a Complete Response Letter dated October 22, 2024, which requested clarifications related to drug substance, product, manufacturing, and microbiology. Notably, no concerns were raised about stability, and no additional clinical studies were required.
PharmaTher aims to address the U.S. Ketamine shortage, which has persisted since February 2018. The FDA issued a compounding risk alert in October 2023 regarding potential risks of compounded Ketamine products. Upon FDA approval and removal from the shortage list, compound pharmacies may face restrictions, positioning PharmaTher to fill the market demand gap.
PharmaTher Holdings (OTCQB: PHRRF) ha ricevuto una Lettera di Riconoscimento dell'Emendamento dalla FDA per la sua Domanda di Nuovo Farmaco a base di Ketamina, con una data obiettivo di approvazione fissata per il 4 giugno 2025. La FDA ha classificato questo come un emendamento minore che qualifica per una revisione prioritaria.
La società ha precedentemente affrontato le carenze di una Lettera di Risposta Completa datata 22 ottobre 2024, che richiedeva chiarimenti relativi alla sostanza del farmaco, al prodotto, alla produzione e alla microbiologia. È importante notare che non sono state sollevate preoccupazioni riguardo alla stabilità e non sono stati richiesti ulteriori studi clinici.
PharmaTher mira a risolvere la carenza di Ketamina negli Stati Uniti, che persiste dal febbraio 2018. La FDA ha emesso un avviso di rischio di composti nell'ottobre 2023 riguardo ai potenziali rischi dei prodotti a base di Ketamina composti. Una volta ottenuta l'approvazione della FDA e rimossa dalla lista delle carenze, le farmacie di compounding potrebbero affrontare restrizioni, posizionando PharmaTher per colmare il divario nella domanda di mercato.
PharmaTher Holdings (OTCQB: PHRRF) ha recibido una Carta de Reconocimiento de Enmienda de la FDA para su Solicitud de Nuevo Medicamento de Ketamina, con una fecha objetivo de aprobación fijada para el 4 de junio de 2025. La FDA clasificó esto como una enmienda menor que califica para revisión prioritaria.
La compañía abordó previamente las deficiencias de una Carta de Respuesta Completa fechada el 22 de octubre de 2024, que solicitaba aclaraciones relacionadas con la sustancia del medicamento, el producto, la fabricación y la microbiología. Es notable que no se plantearon preocupaciones sobre la estabilidad y no se requerían estudios clínicos adicionales.
PharmaTher tiene como objetivo abordar la escasez de Ketamina en EE. UU., que ha persistido desde febrero de 2018. La FDA emitió una alerta de riesgo de compuestos en octubre de 2023 sobre los riesgos potenciales de los productos de Ketamina compuestos. Una vez que se obtenga la aprobación de la FDA y se elimine de la lista de escasez, las farmacias de compuestos podrían enfrentar restricciones, posicionando a PharmaTher para llenar la brecha de demanda del mercado.
PharmaTher Holdings (OTCQB: PHRRF)는 FDA로부터 케타민 신약 신청에 대한 수정 승인 통지서를 받았으며, 승인 목표 날짜는 2025년 6월 4일입니다. FDA는 이를 우선 심사를 위한 경미한 수정으로 분류했습니다.
회사는 2024년 10월 22일자 완전 응답서에서 약물 물질, 제품, 제조 및 미생물학과 관련된 명확한 설명을 요청한 결함을 이전에 해결했습니다. 특히 안정성에 대한 우려는 제기되지 않았으며 추가 임상 연구는 필요하지 않았습니다.
PharmaTher는 2018년 2월 이후 지속되고 있는 미국의 케타민 부족 문제를 해결하는 것을 목표로 하고 있습니다. FDA는 2023년 10월 케타민 제품의 조제 위험에 대한 경고를 발령했습니다. FDA의 승인을 받고 부족 목록에서 제외되면 조제 약국은 제한에 직면할 수 있으며, 이는 PharmaTher가 시장 수요의 격차를 메우는 데 유리한 위치를 차지하게 합니다.
PharmaTher Holdings (OTCQB: PHRRF) a reçu une Lettre de Reconnaissance d'Amendement de la FDA pour sa Demande de Nouveau Médicament à base de Kétamine, avec une date d'objectif d'approbation fixée au 4 juin 2025. La FDA a classé cela comme un amendement mineur qualifiant pour une révision prioritaire.
La société a précédemment résolu les carences d'une Lettre de Réponse Complète datée du 22 octobre 2024, qui demandait des clarifications relatives à la substance médicamenteuse, au produit, à la fabrication et à la microbiologie. Il est à noter qu'aucune préoccupation n'a été soulevée concernant la stabilité et qu'aucune étude clinique supplémentaire n'était requise.
PharmaTher vise à résoudre la pénurie de Kétamine aux États-Unis, qui persiste depuis février 2018. La FDA a émis une alerte sur les risques de produits de Kétamine composés en octobre 2023. Une fois l'approbation de la FDA obtenue et retirée de la liste de pénurie, les pharmacies de composition pourraient faire face à des restrictions, plaçant PharmaTher dans une position favorable pour combler le vide de demande sur le marché.
PharmaTher Holdings (OTCQB: PHRRF) hat von der FDA ein Änderungsbestätigungsschreiben für seinen Antrag auf ein neues Ketamin-Medikament erhalten, mit einem Genehmigungszieltermin am 4. Juni 2025. Die FDA hat dies als geringfügige Änderung eingestuft, die für eine vorrangige Prüfung qualifiziert ist.
Das Unternehmen hat zuvor Mängel in einem vollständigen Antwortschreiben vom 22. Oktober 2024 angesprochen, in dem Klarstellungen zu Arzneistoff, Produkt, Herstellung und Mikrobiologie angefordert wurden. Bemerkenswerterweise wurden keine Bedenken hinsichtlich der Stabilität geäußert, und es waren keine zusätzlichen klinischen Studien erforderlich.
PharmaTher zielt darauf ab, die Ketamin-Knappheit in den USA zu beheben, die seit Februar 2018 besteht. Die FDA gab im Oktober 2023 eine Warnung zu den Risiken von zusammengesetzten Ketamin-Produkten heraus. Nach der Genehmigung durch die FDA und der Streichung von der Mangel-Liste könnten Apotheken mit Einschränkungen konfrontiert werden, was PharmaTher in eine gute Position bringt, um die Marktnachfrage zu decken.
- FDA classified amendment as minor with priority review status
- No additional clinical studies required by FDA
- No stability concerns raised for submission batches
- Potential to become leading supplier after FDA approval
- Strategic positioning to capture market share once compounded products are restricted
- Current FDA approval still pending until June 2025
- Previous Complete Response Letter indicated multiple deficiencies
- Competition from existing compound pharmacies until restrictions implemented
The Assigned FDA Approval Goal Date is June 4, 2025
TORONTO, March 11, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company hyper-focused on the commercialization of Ketamine, is pleased to announce today that the Company has received an Amendment Acknowledgement Letter (“AAL”) from the U.S. Food and Drug Administration (“FDA”) for its New Drug Application for Ketamine. In the AAL, the FDA determined this is a minor amendment, meets the criteria for priority review, and assigned an approval goal date of June 4, 2025.
Fabio Chianelli, Chairman and CEO of PharmaTher, commented:
“I am very pleased with the new FDA approval goal date of June 4, 2025 for our Ketamine drug. We are focused on solving the shortage issue of Ketamine and becoming the leading supplier of Ketamine to fill the demand gap in the U.S. market.”
Expecting FDA approval of Ketamine on or before June 4, 2025
As announced on March 3, 2025, PharmaTher provided its resubmission to the complete response amendment and has addressed the deficiencies classified as MINOR in the complete response letter (“CRL”) dated October 22, 2024. In the CRL, 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. No additional deficiencies were mentioned in the AAL. The Company, demonstrating its commitment to quality and compliance, promptly completed the necessary tests and responses to address the FDA’s comments and submitted them to the FDA for their review, which resulted in a new approval goal date of June 4, 2025.
Solving the Ketamine shortage problem in the U.S.
PharmaTher is committed to 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.
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 drug shortage list and compounders have a 60- to 90-day grace period to stop supplying them (see FDA letter).
With ketamine removed from the FDA drug shortage list, the FDA is expected to restrict compound pharmacies from supplying it, opening the door for PharmaTher to fill the demand gap in the U.S. market.
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 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 significantly impact 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 hyper-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.
FAQ
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