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

Rhea-AI Summary

PharmaTher Holdings (OTCQB: PHRRF) announced that the FDA granted their request for a post-complete letter clarification meeting following a Complete Response Letter (CRL) received on October 22, 2024, regarding their ketamine Abbreviated New Drug Application. The meeting, initially scheduled for November 29, 2024, is pending rescheduling due to the U.S. Thanksgiving Holiday. The CRL deficiencies are classified as minor, requiring new information related to drug substance, product, manufacturing, and microbiology. No concerns were raised about ketamine stability or need for additional clinical studies. The company aims to address the U.S. ketamine shortage, noting that ketamine has been on the FDA's drug shortage list since February 2018.

Positive

• CRL deficiencies classified as minor, indicating less severe regulatory hurdles
• No additional clinical studies required by FDA
• Ketamine submission batches achieved 18 months stability without issues
• Addressing existing market opportunity with ketamine shortage since 2018

Negative

• FDA approval delayed due to Complete Response Letter
• Additional information required for drug substance, product, manufacturing, and microbiology
• Meeting delay due to scheduling conflicts

TORONTO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- 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

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “closer”, "could", “confident”, "would", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim", “may”, “plan”, “proposed”, “lead”, “toward”, “anticipate”, and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the year ended May 31, 2024 originally filed on September 26, 2024, has been refiled to correct the date of the MD&A from “September 23, 2024” to “September 26, 2024”, which is available on the Company's profile at www.sedarplus.ca.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

FAQ

What were the FDA's requirements in the Complete Response Letter for PharmaTher's (PHRRF) ketamine application?

The FDA requested new and updated information related to drug substance, drug product, manufacturing, and microbiology. The deficiencies were classified as minor, and no new preclinical or clinical studies were required.

When did PharmaTher (PHRRF) receive the Complete Response Letter for their ketamine application?

PharmaTher received the Complete Response Letter (CRL) from the FDA on October 22, 2024.

What is the status of PharmaTher's (PHRRF) FDA clarification meeting for their ketamine application?

The FDA granted a clarification meeting initially scheduled for November 29, 2024, but it's being rescheduled due to the U.S. Thanksgiving Holiday and CDMO partner scheduling conflicts.

How long has ketamine been on the FDA's drug shortage list?

Ketamine has been on the FDA's drug shortage list since February 2018.