Will PharmaTher be the next company to get a psychedelic medicine to market? This is the firm’s game plan as it submits a New Drug Application to the FDA.

PharmaTher has submitted a priority original Abbreviated New Drug Application (“ANDA”) for its KETARX (racemic ketamine) to the Food and Drug Administration for expedited review.

The company’s KETARX ketamine program seems to have FDA support, receiving 5 different Orphan Drug designations by the FDA:

1. Treatment of Rett Syndrome;
2. Prevention of Ischemia-reperfusion injury from organ transplantation;
3. Treatment of Status Epilepticus;
4. Treatment of Amyotrophic Lateral Sclerosis; and
5. Treatment of Complex Regional Pain Syndrome.

The company has also completed a successful Phase 2 study using KETARX for Parkinson’s Disease, with a Phase 3 trial for Parkinson’s being planned now. Along with several patents in place, this gives PharmaTher a strong portfolio of niche developments reaching a very advanced stage.

According to their press release:

The Company anticipates KETARX approval and commercial launch in the U.S. in Q2-2024, followed by the pursuit of international approvals to support the growing global demand for ketamine.

PharmaTher’s priority is to commercialize KETARX in the U.S. under ketamine’s FDA-approved label through its recently announced partnership with Vitruvias Therapeutics, Inc., a leading U.S. based specialty generic pharmaceutical company. The Company expects to market various dosage forms of KETARX, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets.

If this timeline is accurate, PharmaTher could give the industry quite a surprise in 2024. Stay tuned.

For more on PharmaTher check out PharmaTher Granted Patent For Ketamine and Parkinson’s and Heading to Phase 3? PharmaTher Announces Positive Results for Ketamine Trial

PharmaTher Submits Priority Original Abbreviated New Drug Application for KETARX (Ketamine) to the FDA

September 06, 2023 07:30 ET| Source: PharmaTher Holdings Ltd.

TORONTO, Sept. 06, 2023 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, is pleased to announce it has submitted a priority original Abbreviated New Drug Application (“ANDA”) for KETARX (racemic ketamine) to the Food and Drug Administration (“FDA”) for expedited review of its ANDA. The Company anticipates KETARX approval and commercial launch in the U.S. in Q2-2024, followed by the pursuit of international approvals to support the growing global demand for ketamine.

“The submission of the ANDA for ketamine is a significant milestone for PharmaTher that brings us one step closer to becoming a global leader in ketamine and a commercial-focused specialty pharmaceutical company offering drugs that are in short supply with growing adoption for on-label and clinical needs,” said Fabio Chianelli, CEO of PharmaTher. “Ketamine has been on the FDA’s drug shortage list for over 5 years and its potential for mental health, neurological, and pain disorders continues to gain momentum and validation through published clinical research and real-world use cases.”

Ketamine is an essential medicine used for anaesthesia and analgesia (pain relief) listed on the WHO Essential Medicines List. Ketamine has been on the FDA’s drug shortage list since February 2018. 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.

PharmaTher’s priority is to commercialize KETARX in the U.S. under ketamine’s FDA-approved label through its recently announced partnership with Vitruvias Therapeutics, Inc., a leading U.S. based specialty generic pharmaceutical company. The Company expects to market various dosage forms of KETARX, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) develops and commercializes specialty pharmaceuticals exhibiting growing adoption and permitting novel delivery methods to enhance patient outcomes. The Company’s lead product is KETARX (racemic ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, and neurological indications. The Company is commercializing PharmaPatch (microneedle patch) with its partners to deliver psychedelics and drugs to treat infectious diseases. Learn more at PharmaTher.com.

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