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 Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
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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.
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