PharmaTher Announces Update on FDA New Drug Application for Ketamine
PharmaTher Holdings (OTCQB: PHRRF) announced an update on its New Drug Application for Ketamine with the FDA. The FDA has assigned a GDUFA goal date of October 29, 2024, and confirmed that the review is ongoing with no additional information needed at this time. Following anticipated FDA approval, PharmaTher aims to pursue international approvals and explore novel uses and delivery methods of ketamine for various indications. The company's goal is to address the ketamine shortage in the U.S., which has been on the FDA's drug shortage list since February 2018. PharmaTher's ketamine will adhere to strict FDA manufacturing guidelines and prescribing labels, addressing concerns about compounded ketamine products not approved for psychiatric disorders.
PharmaTher Holdings (OTCQB: PHRRF) ha annunciato un aggiornamento sulla sua Domanda di Nuovo Farmaco per la Ketamina presso la FDA. La FDA ha fissato una data obiettivo GDUFA per il 29 ottobre 2024 e ha confermato che la revisione è in corso senza la necessità di ulteriori informazioni in questo momento. Dopo l'atteso approvazione della FDA, PharmaTher intende perseguire approvazioni internazionali ed esplorare nuovi usi e metodi di somministrazione della ketamina per varie indicazioni. L'obiettivo della compagnia è affrontare la carenza di ketamina negli Stati Uniti, che è presente nella lista delle carenze di farmaci della FDA da febbraio 2018. La ketamina di PharmaTher seguirà rigide linee guida di produzione e prescrizione della FDA, affrontando preoccupazioni sui prodotti di ketamina composti non approvati per disturbi psichiatrici.
PharmaTher Holdings (OTCQB: PHRRF) anunció una actualización sobre su Solicitud de Nuevo Medicamento para la Ketamina ante la FDA. La FDA ha asignado una fecha objetivo GDUFA del 29 de octubre de 2024 y ha confirmado que la revisión está en curso sin necesidad de información adicional en este momento. Tras la esperada aprobación de la FDA, PharmaTher tiene como objetivo buscar aprobaciones internacionales y explorar nuevos usos y métodos de entrega de la ketamina para diversas indicaciones. El objetivo de la compañía es abordar la escasez de ketamina en EE. UU., que ha estado en la lista de escasez de medicamentos de la FDA desde febrero de 2018. La ketamina de PharmaTher se ajustará a estrictas pautas de fabricación y etiquetas de prescripción de la FDA, abordando las preocupaciones sobre los productos de ketamina compuestos no aprobados para trastornos psiquiátricos.
PharmaTher Holdings (OTCQB: PHRRF)는 FDA에 대한 케타민의 신약 승인 신청에 대한 업데이트를 발표했습니다. FDA는 2024년 10월 29일을 GDUFA 목표 날짜로 지정했으며, 현재 추가 정보가 필요하지 않다고 확인했습니다. FDA의 승인 이후, PharmaTher는 국제 승인을 추구하고 다양한 적응증을 위한 케타민의 새로운 사용 및 전달 방법 탐색을 목표로 하고 있습니다. 회사의 목표는 2018년 2월부터 FDA의 약물 부족 목록에 포함된 미국의 케타민 부족 문제를 해결하는 것입니다. PharmaTher의 케타민은 FDA의 엄격한 제조 지침과 처방 라벨을 준수하여, 정신과적 질환에 승인되지 않은 복합 케타민 제품에 대한 우려를 해소할 것입니다.
PharmaTher Holdings (OTCQB: PHRRF) a annoncé une mise à jour concernant sa Demande de Nouveau Médicament pour la kétamine auprès de la FDA. La FDA a fixé une date limite GDUFA au 29 octobre 2024 et a confirmé que l'examen est en cours sans qu'aucune information supplémentaire ne soit nécessaire à ce stade. Après l'approbation anticipée de la FDA, PharmaTher vise à obtenir des approbations internationales et à explorer de nouvelles utilisations et méthodes d'administration de la kétamine pour diverses indications. L'objectif de l'entreprise est de remédier à la pénurie de kétamine aux États-Unis, qui figure sur la liste des pénuries de médicaments de la FDA depuis février 2018. La kétamine de PharmaTher respectera les directives strictes de fabrication et les étiquettes de prescription de la FDA, répondant ainsi aux inquiétudes concernant les produits de kétamine composés non approuvés pour les troubles psychiatriques.
PharmaTher Holdings (OTCQB: PHRRF) hat ein Update zu ihrem Antrag auf Neuzulassung für Ketamin bei der FDA angekündigt. Die FDA hat ein GDUFA-Zieldatum für den 29. Oktober 2024 festgelegt und bestätigt, dass die Überprüfung im Gange ist und derzeit keine weiteren Informationen benötigt werden. Nach der erwarteten Genehmigung durch die FDA beabsichtigt PharmaTher, internationale Genehmigungen zu verfolgen und neue Anwendungsmöglichkeiten und Verabreichungsmethoden für Ketamin zu erkunden, die für verschiedene Indikationen relevant sind. Das Ziel des Unternehmens ist es, die Ketamin-Engpässe in den USA zu beheben, die seit Februar 2018 auf der Liste der Arzneimittelengpässe der FDA stehen. Das Ketamin von PharmaTher wird strengen FDA-Herstellungsrichtlinien und Verschreibungslabeln entsprechen und Bedenken hinsichtlich nicht zugelassener, zusammengesetzter Ketaminprodukte für psychiatrische Störungen ansprechen.
- FDA review of Ketamine New Drug Application is ongoing with a goal date of October 29, 2024
- Company plans to pursue international approvals after anticipated FDA approval
- Aims to address the ketamine shortage problem in the U.S.
- Potential to expand into novel uses and delivery methods for various indications
- FDA approval is not guaranteed and is still pending
- Potential competition from compounded ketamine products in the market
TORONTO, Sept. 04, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced an update for its New Drug Application for Ketamine from the U.S. Food and Drug Administration (the “FDA”) with an assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. On September 3, 2024, the FDA communicated with the Company that the review is ongoing and no additional information is needed, but is subject to change. The Company will continue to provide updates as they occur.
Following the anticipated FDA approval and launch in the U.S., the Company aims to pursue international approvals to support the global demand for ketamine and its commercial development strategy to treat Parkinson’s Disease. In addition, the Company will pursue novel uses and delivery methods of ketamine for mental health, pain, neurological and medical countermeasures indications.
The Company’s overall goal is to solve the ketamine shortage problem in the U.S. and its ketamine 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. In Canada, ketamine has been classified as a Tier 3 drug shortage since February 2023, and 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 three and nine months ended February 29, 2024 ("MD&A"), dated April 19, 2024, which is available on the Company's profile at www.sedarplus.ca.
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FAQ
What is the FDA goal date for PharmaTher's Ketamine New Drug Application?
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