PharmaTher Provides Update for Expected FDA Approval of Ketamine
PharmaTher Holdings Ltd. (PHRRF) is on track to receive FDA approval for its lead drug, ketamine, with an assigned approval goal date of April 29, 2024. The company aims to address the ketamine shortage problem in the U.S. and anticipates the commercial launch of ketamine in 2024, followed by international approvals. Ketamine has potential applications in anesthesia, sedation, pain, mental health, and neurological disorders, with recent studies demonstrating its effectiveness in treating depression, anxiety, and suicidal ideation.
01/10/2024 - 07:30 AM
Assigned FDA approval goal date of April 29, 2024, is still on track
TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, is pleased to provide an update for the Company’s lead drug, ketamine (“KETARX™”), as a potential treatment for anesthesia, sedation, pain, mental health, and neurological indications. On September 27, 2023, the Company announced that the U.S. Food and Drug Administration (“FDA”) had accepted the priority original Abbreviated New Drug Application (“ANDA”) for ketamine and assigned an approval goal date of April 29, 2024. The assigned FDA approval goal date is still on track.
Fabio Chianelli, CEO of PharmaTher, commented: “We believe 2024 will be a transformative year for PharmaTher with the expected FDA approval of ketamine having an assigned goal date for approval on April 29, 2024. In anticipation of a potential FDA approval, we are focusing on the commercial scale-up of ketamine in the U.S. and seeking additional international approvals.”
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.
The Company’s overall goal is to solve the ketamine shortage problem in the U.S. and anticipates the commercial launch of ketamine in 2024, and will meet the FDA’s strict manufacturing guidelines and FDA-approved prescribing label . KETARX™ will be produced in the U.S. in a cGMP manufacturing facility that is DEA certified and inspected by domestic and international regulatory agencies, including the FDA and EU EMA.
Following the FDA approval and launch in the U.S., the Company will pursue international approvals to support the global demand for ketamine. Ketamine is an essential medicine used for anesthesia and analgesia (pain relief) listed on the WHO Essential Medicines List . In Canada, ketamine has been classified as a Tier 3 drug shortage since February 2023, and 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.
The Company’s long-term strategy is pursuing novel uses and delivery methods of ketamine as a potential treatment for pain, mental health, and neurological disorders. In anticipation of a potential FDA approval for ketamine, the Company will allocate funds to the U.S. commercial scale-up and international regulatory approvals, and pause funding for its product and clinical programs, including its microneedle patch and on-body pump systems, Parkinson’s disease, Amyotrophic Lateral Sclerosis, Rett Syndrome, and Complex Regional Pain Syndrome for the first half of 2024. The Company will evaluate these programs quarterly to determine a potential rationale for reviving one or more of them internally or with potential pharmaceutical partners.
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, and neurological indications. Learn more at PharmaTher.com
For more information about PharmaTher, please contact:
Fabio Chianelliinfo@pharmather.com 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 "could", "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 three months ended August 31, 2023 ("MD&A"), dated October 26, 2023, 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.
When is PharmaTher Holdings Ltd. expected to receive FDA approval for ketamine?
The company is on track to receive FDA approval for ketamine with an assigned goal date of April 29, 2024.
What are the potential applications of ketamine?
Ketamine has potential applications in anesthesia, sedation, pain, mental health, and neurological disorders, with recent studies demonstrating its effectiveness in treating depression, anxiety, and suicidal ideation.
What is the current status of the ketamine shortage problem in the U.S.?
The company aims to address the ketamine shortage problem in the U.S. and anticipates the commercial launch of ketamine in 2024, followed by international approvals.
What recent study findings support the effectiveness of ketamine?
A recent peer-reviewed study on the real-world effectiveness of ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety, and suicidal ideation.
What is PharmaTher Holdings Ltd.'s long-term strategy for ketamine?
The company's long-term strategy involves pursuing novel uses and delivery methods of ketamine as a potential treatment for pain, mental health, and neurological disorders.
