Toronto-based PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is expecting to get full approval from the U.S. Food and Drug Administration (FDA) in April for a ketamine-based treatment it’s developed to be used for a wide array of “pain, mental health, and neurological disorders,” the company announced Wednesday.
PharmaTher had submitted an application to the FDA last year for its ketamine-based drug KETARX, which it had indicated at the time could be used to combat Parkinson’s Disease. The company said it learned in September that the FDA set an “approval goal date” of April 29, 2024, and reported this week that it had confirmed that the date is “still on track.”
If KETARX gets the thumbs up from the FDA, PharmaTher said it intends to restart a wider range of treatment products and regimens that target far more ailments than just Parkinson’s Disease. Rather, the company said in a press release that its “long-term strategy is pursuing novel uses and delivery methods of ketamine as a potential treatment for pain, mental health, and neurological disorders.”
That includes backfilling a national ketamine shortage, applying for government approvals in other countries for KETARX, and ongoing product research and development, PharmaTher indicated.
PharmaTher is confident enough that it’s getting the green light from the FDA that it said it’s proceeding with the reallocation of company funds for “the U.S. commercial scale-up and international regulatory approvals,” while it hits “pause” on spending for “product and clinical programs.”
Those programs – including treatments for Parkinson’s disease, Amyotrophic Lateral Sclerosis, Rett Syndrome, and Complex Regional Pain Syndrome – may be restarted in the second half of the year if PharmaTher can find the right partners with whom to run them.
“We believe 2024 will be a transformative year for PharmaTher with the expected FDA approval of ketamine,” PharmaTher CEO Fabio Chianelli said in a release.
Following the approval, KETARX will be manufactured in the U.S. at a federally certified facility, and then PharmaTher will turn to Canada, where there’s also been a ketamine shortage since February 2023.
Ketamine is used in Canada as a sedative and painkiller, as opposed to solely for specific ailments such as Parkinson’s Disease, PharmaTher noted. It’s also “administered in hospitals and clinics to treat various mental health, neurological and pain disorders,” the company said in its release, and cited a recent study that found positive results from ketamine in patients dealing with “depression, anxiety, and suicidal ideation.”