PharmaTher Receives Complete Response Letter from the U.S. Food and Drug Administration for Ketamine Abbreviated New Drug Application
PharmaTher Holdings (OTCQB: PHRRF) received a Complete Response Letter (CRL) from the FDA for its ketamine Abbreviated New Drug Application. The FDA cited minor deficiencies requesting new information related to drug substance, product, manufacturing, and microbiology. No concerns were expressed about stability testing, and no additional preclinical or clinical studies were required. The resubmission will be classified as a minor amendment. 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. The FDA recently issued a risk alert about non-FDA-approved compounded ketamine products for psychiatric disorders.
PharmaTher Holdings (OTCQB: PHRRF) ha ricevuto una Lettera di Risposta Completa (CRL) dalla FDA per la sua Domanda Abbreviata di Nuovo Farmaco a base di ketamina. La FDA ha citato piccole carenze, richiedendo nuove informazioni relative al principio attivo, al prodotto, alla produzione e alla microbiologia. Non sono state espresse preoccupazioni sui test di stabilità e non sono stati richiesti studi preclinici o clinici aggiuntivi. La nuova presentazione sarà classificata come una modifica minore. L'azienda mira ad affrontare la carenza di ketamina negli Stati Uniti, notando che la ketamina figura nella lista delle carenze di farmaci della FDA dal febbraio 2018. La FDA ha recentemente emesso un avviso di rischio riguardo ai prodotti a base di ketamina non approvati dalla FDA per disturbi psichiatrici.
PharmaTher Holdings (OTCQB: PHRRF) recibió una Carta de Respuesta Completa (CRL) de la FDA para su Solicitud Abreviada de Nuevo Medicamento de ketamina. La FDA citó pequeñas deficiencias, solicitando nueva información relacionada con la sustancia activa, el producto, la fabricación y la microbiología. No se expresaron preocupaciones sobre las pruebas de estabilidad, y no se requerían estudios preclínicos o clínicos adicionales. La re-presentación se clasificará como una enmienda menor. La empresa busca abordar la escasez de ketamina en EE.UU., señalando que la ketamina ha estado en la lista de escasez de medicamentos de la FDA desde febrero de 2018. La FDA emitió recientemente una alerta de riesgo sobre productos de ketamina compuestos no aprobados por la FDA para trastornos psiquiátricos.
PharmaTher Holdings (OTCQB: PHRRF)는 FDA로부터 케타민 약물의 간소화 신약 신청에 대한 완전응답서(CRL)를 받았습니다. FDA는 약물 성분, 제품, 제조 및 미생물학과 관련된 경미한 결함을 지적하며 새로운 정보를 요청했습니다. 안정성 테스트에 대한 우려는 없었고, 추가적인 전임상이나 임상 연구도 필요하지 않았습니다. 재제출은 경미한 수정으로 분류될 것입니다. 회사는 케타민 부족 문제를 해결하는 것을 목표로 하고 있으며, 케타민은 2018년 2월부터 FDA의 약물 부족 목록에 등재되어 있음을 주목하고 있습니다. FDA는 정신 장애를 위한 비 FDA 승인 혼합 케타민 제품에 대한 위험 경고를 최근 발표했습니다.
PharmaTher Holdings (OTCQB: PHRRF) a reçu une Lettre de Réponse Complète (CRL) de la FDA concernant sa Demande Abbrégée de Nouveau Médicament pour la kétamine. La FDA a cité de petites carences, demandant de nouvelles informations relatives à la substance médicamenteuse, au produit, à la fabrication et à la microbiologie. Aucune préoccupation n'a été exprimée concernant les tests de stabilité, et aucune étude préclinique ou clinique supplémentaire n'a été requise. La nouvelle soumission sera classée comme une modification mineure. L'entreprise vise à répondre à la pénurie de kétamine aux États-Unis, notant que la kétamine figure sur la liste des pénuries de médicaments de la FDA depuis février 2018. La FDA a récemment émis un avertissement sur les produits de kétamine composés non approuvés par la FDA pour les troubles psychiatriques.
PharmaTher Holdings (OTCQB: PHRRF) hat von der FDA einen vollständigen Antwortbrief (CRL) für seinen verkürzten Antrag auf ein neues Medikament für Ketamin erhalten. Die FDA nannte geringe Mängel und forderte neue Informationen zu Wirkstoff, Produkt, Herstellung und Mikrobiologie an. Es wurden keine Bedenken hinsichtlich der Stabilitätstests geäußert, und es waren keine zusätzlichen präklinischen oder klinischen Studien erforderlich. Die erneute Einreichung wird als geringfügige Änderung eingestuft. Das Unternehmen beabsichtigt, die Ketamin-Engpässe in den USA anzugehen, da Ketamin seit Februar 2018 auf der Liste der Medikamentenengpässe der FDA steht. Die FDA hat kürzlich eine Risikowarnung zu nicht von der FDA genehmigten, zusammengesetzten Ketaminprodukten für psychiatrische Störungen herausgegeben.
- FDA classified deficiencies as minor, requiring no additional clinical studies
- Ketamine submission batches achieved 18 months stability without issues
- Resubmission will be considered a minor amendment
- FDA Complete Response Letter delays potential drug approval
- Additional information and clarifications required for multiple aspects of the application
TORONTO, Oct. 23, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued 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.
The deficiencies cited in the CRL are 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.
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 Company will be working with its third-party manufacturing partner to resolve these deficiencies and respond to the FDA in a timely fashion. The Company will provide a timeline for responding to the FDA as soon as possible and continue to provide updates as they occur.
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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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”, 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 year ended May 31, 2024 originally filed on September 26, 2024, has been refiled to correct the date of the MD&A from “September 23, 2024” to “September 26, 2024”, which is available on the Company's profile at www.sedarplus.ca.
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FAQ
What was the FDA's response to PharmaTher's (PHRRF) ketamine application in October 2024?
How long has ketamine been on FDA's drug shortage list?
What type of stability results did PharmaTher (PHRRF) achieve for their ketamine submission?
When did the FDA issue their compounding risk alert for ketamine products?
