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Highlights:
- PharmaTher receives a complete response letter from the FDA regarding its ketamine application.
- The FDA classified the deficiencies as minor, requiring updates on specific manufacturing details.
- The company is committed to resolving issues promptly to address the ongoing ketamine shortage in the U.S.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on innovative therapies, has announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for its Abbreviated New Drug Application (ANDA) for ketamine, dated October 22, 2024. This letter comes just a week before the scheduled GDUFA goal date of October 29, 2024, indicating the agency's feedback on the application submitted by PharmaTher.
The FDA cited deficiencies in its CRL that have been classified as minor. Specifically, the agency requested new and updated information regarding various aspects of the drug substance and drug product, including manufacturing processes and microbiology data. Importantly, the FDA did not express any concerns about the stability of the ketamine batches submitted, which have demonstrated stability for 18 months. Additionally, no new preclinical or clinical studies are required, which could facilitate a quicker resolution.
PharmaTher is committed to addressing the deficiencies identified in the CRL and will collaborate with its third-party manufacturing partner to resolve the issues. The company plans to respond to the FDA promptly and will provide updates regarding its timeline for resubmission as developments unfold. The classification of the deficiencies as minor suggests that the process to rectify the concerns should be manageable and not overly burdensome.
The need for ketamine in the U.S. is critical, as it has been on the FDA's drug shortage list since February 2018. This shortage has led to a rise in the availability of compounded ketamine products that are not FDA-approved for psychiatric disorders, posing potential risks to patients. On October 10, 2023, the FDA issued a compounding risk alert outlining the dangers associated with these unregulated products, particularly those distributed by telehealth providers offering in-home ketamine services. This situation underscores the importance of bringing a safe, FDA-approved ketamine product to market.
Ketamine is recognized as an essential medicine by the World Health Organization (WHO), primarily used for anesthesia and pain relief. Health Canada has already approved its use as a sedative in hospital settings. Moreover, ketamine is being explored for various off-label uses in hospitals and clinics, including treatments for mental health disorders, neurological issues, and pain management. Recent peer-reviewed studies have highlighted its effectiveness, showcasing substantial patient improvements through intravenous therapy.
PharmaTher remains resolute in its goal to alleviate the ketamine shortage in the U.S. while adhering to FDA manufacturing guidelines and approved prescribing labels. As the company navigates this minor setback, its ongoing commitment to patient safety and drug efficacy remains a top priority. The response to the FDA’s complete response letter will be a crucial step in PharmaTher’s journey to delivering a reliable ketamine solution to healthcare providers and patients in need.
