PharmaTher Updates FDA Ketamine Drug Application

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, has provided updates on its New Drug Application (NDA) for Ketamine with the U.S. Food and Drug Administration (FDA). The FDA has set a Generic Drug User Fee Amendments of 2022 (GDUFA) goal date of October 29, 2024, for the review of the application. On September 3, 2024, the FDA informed PharmaTher that the review is ongoing and currently requires no additional information, although this is subject to change. The company will keep stakeholders informed as more updates become available.

Once the FDA approves the NDA, PharmaTher plans to seek international approvals to meet the global demand for ketamine. This forms part of the company’s broader commercial strategy to use ketamine in the treatment of Parkinson’s Disease and explore novel uses and delivery methods for conditions such as mental health disorders, pain management, and various neurological applications.

PharmaTher’s mission includes addressing the ketamine shortage in the U.S. and ensuring that its ketamine product complies with the FDA’s stringent manufacturing guidelines and approved prescribing label. Ketamine has been on the FDA’s drug shortage list since February 2018. This shortage has likely contributed to the increased availability of compounded ketamine products, which are not FDA-approved for psychiatric disorders. On October 10, 2023, the FDA issued an alert highlighting the potential risks of compounded ketamine, particularly from telehealth providers offering in-home ketamine services. These compounded products lack FDA approval.

Ketamine is recognized as an essential medicine for anesthesia and pain relief, and it is included in the World Health Organization's (WHO) Essential Medicines List. In Canada, ketamine has been designated a Tier 3 drug shortage since February 2023, and Health Canada has approved its use as a sedative and painkiller in hospitals. Beyond these approved uses, ketamine is also administered in various healthcare settings to treat mental health, neurological, and pain disorders. Recent peer-reviewed research has shown that intravenous ketamine therapy significantly improves conditions such as depression, anxiety, and suicidal ideation.

PharmaTher is focused on the development and commercialization of KETARX™ (Ketamine) to address global medical needs across various indications, including anesthesia, sedation, pain management, mental health disorders, neurological conditions, and medical countermeasures. Additionally, PharmaTher owns 49% of Sairiyo Therapeutics Inc., which is working on the clinical development of an improved, patented formulation of cepharanthine (PD-001) for treating viral infectious diseases and other medical countermeasures.

The company's efforts aim to ensure a stable supply of ketamine that meets rigorous regulatory standards, thereby addressing ongoing shortages and expanding the therapeutic applications of this essential medicine. PharmaTher continues to advance its drug development pipeline, aiming to provide effective solutions for a range of medical conditions and unmet healthcare needs worldwide.

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