PharmaTher Updates on FDA Ketamine Drug Application

PharmaTher Holdings Ltd., a specialty pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has scheduled a post-complete letter clarification meeting for December 2, 2024. This comes after the FDA issued a complete response letter (CRL) on October 22, 2024, regarding the ketamine Abbreviated New Drug Application. The CRL, which had a Generic Drug User Fee Amendments of 2022 (GDUFA) goal date of October 29, 2024, cited several minor deficiencies that need to be addressed.

PharmaTher has already begun taking measures to address the issues identified in the CRL. The FDA's letter highlighted the need for new and updated information, as well as clarifications concerning drug substance, drug product, manufacturing, and microbiology. Importantly, the FDA did not raise any concerns about the stability of the ketamine submission batches, which have maintained stability for 18 months. Additionally, no new preclinical or clinical studies have been requested by the FDA. The resubmission to address the CRL will be classified as a minor amendment, as indicated by the FDA.

PharmaTher has stated that they will announce a proposed timeline for the resubmission after the scheduled meeting with the FDA and will continue to provide updates as they progress.

PharmaTher Holdings Ltd. focuses on the development and commercialization of KETARX™ (Ketamine) to meet global medical needs in anesthesia, sedation, pain management, mental health, neurological conditions, and medical countermeasures. The company also owns a 49% stake in Sairiyo Therapeutics Inc., which is dedicated to advancing the clinical development of a patented enteric-coated orally bioavailable formulation of cepharanthine (PD-001) for viral infectious diseases and medical countermeasures.