PharmaTher Announces FDA Goal Date for Priority Ketamine Drug Application

PharmaTher Holdings Ltd., a specialty pharmaceutical company, announced the receipt of an Amendment Acknowledgment Letter (AAL) for its Priority Original Abbreviated New Drug Application (ANDA) for Ketamine from the U.S. Food and Drug Administration (FDA). The FDA also assigned a Generic Drug User Fee Amendments of 2022 (GDUFA) goal date of October 29, 2024.

Previously, on April 18, 2024, the company received a Complete Response Letter (CRL) from the FDA, which highlighted potential deficiencies in its application. These issues were similar to those identified in a review letter from February 12, 2024. No new deficiencies were cited in either the CRL or AAL. PharmaTher promptly addressed the FDA’s comments by completing the required tests and submitting the results for review. This led to the assignment of the GDUFA goal date.

PharmaTher's mission is to address the ketamine shortage in the U.S. while adhering to the FDA’s stringent manufacturing guidelines and approved prescribing labels. After the anticipated FDA approval, the company plans to seek international approvals to meet global demand for ketamine. The long-term objective is to explore novel uses and delivery methods of ketamine for treating pain, mental health, and neurological disorders.

Ketamine has been on the FDA’s drug shortage list since February 2018, partly due to the rise of non-FDA approved compounded ketamine products for psychiatric disorders. On October 10, 2023, the FDA issued a compounding risk alert about the dangers of these compounded ketamine products, especially those provided by telehealth services for in-home treatments.

Ketamine is a crucial medicine for anesthesia and analgesia, listed on the WHO Essential Medicines List. In Canada, it has been classified as a Tier 3 drug shortage since February 2023, with Health Canada approving its use as a sedative and painkiller in hospitals. Beyond FDA and Health Canada approved uses, ketamine is also being used in hospitals and clinics to treat various mental health, neurological, and pain disorders. A recent peer-reviewed study highlighted the significant benefits of ketamine intravenous therapy for patients with depression, anxiety, and suicidal ideation.

PharmaTher Holdings Ltd. is dedicated to the development and commercialization of KETARX™ (Ketamine) to meet the global medical needs for anesthesia, sedation, pain management, mental health, and neurological disorders. The company also owns 49% of Sairiyo Therapeutics Inc., which is focused on advancing the clinical development of an improved, patented enteric-coated orally bioavailable formulation of cepharanthine (PD-001) for treating responsive cancers and infectious diseases, including COVID-19.

PharmaTher remains committed to updating stakeholders as new developments occur in the approval process of its ketamine product. The company aims to play a significant role in solving the ketamine shortage and providing safe, effective treatment options for various medical conditions.