PharmaTher Announces Post Complete Response Letter Clarification Meeting Request Granted from the FDA for Ketamine Abbreviated New Drug Application

TORONTO, November 13, 2024 -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the Company requested a post-complete letter clarification meeting (the “Meeting”) in response to the FDA issuing a complete response letter (CRL), dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024.

On November 12, 2024, the FDA granted the Meeting scheduled for November 29, 2024. Due to the U.S. Thanksgiving Holiday and scheduling conflicts of attendees from its CDMO partner, the Company has requested to reschedule the Meeting for the following week. The Company requested the Meeting to ensure responses to the CRL align with the FDA's requests, leaving nothing to chance. The Company will announce the new Meeting date once it becomes available, propose a timeline for the resubmission to this CRL, and continue to provide updates as they occur.

As announced on October 23, 2024, the deficiencies cited in the CRL are classified as MINOR, and the resubmission to this CRL will be considered a MINOR AMENDMENT. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested.

The Company is committed to its overall goal to solve the ketamine shortage problem in the U.S. and 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. 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 49% of Sairiyo Therapeutics Inc., which focuses on advancing the clinical development of an improved and patented enteric-coated orally bioavailable formulation of cepharanthine (PD-001) for viral infectious diseases and medical countermeasures. Learn more at PharmaTher.com.

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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