Specialty biotech company PharmaTher Holdings (OTCQB:PHRRF) reported it has submitted a priority-original Abbreviated New Drug Application (ANDA) for its proprietary racemic ketamine, KETARX, to the FDA.
The company expects the agency will perform an expedited review of its ANDA, and anticipates KETARX's approval and commercial launch in the U.S. in the second quarter of 2024. Following that, efforts for international approvals to support ketamine's "growing global demand" will be made, PharmaTher stated.
A developer and vendor of specialty pharmaceuticals with growing adoption and novel delivery methods for better patient outcomes, the company's lead drug candidate KETARX aims to "fill the global unmet medical needs for anesthesia, sedation, pain, mental health and neurological indications." Meanwhile, it is advancing microneedle patch PharmaPatch for the delivery of psychedelics, working jointly with partner companies.
The company's stated priority is commercializing KETARX in the U.S. under ketamine's FDA-approved label through its recent partnership with specialty generic pharmaceutical company Vitruvias Therapeutics. In the future, it expects to market various dosage forms of KETARX, with the option to increase concentration and ready-to-administer applications.
In this sense, CEO Fabio Chianelli called the new ANDA represents a significant milestone that would bring PharmaTher one step closer to becoming "a global leader in ketamine" and a commercially-focused specialty company, "offering drugs that are in short supply with growing adoption for on-label and clinical needs."
Chianelli added that ketamine "has been on the FDA's drug shortage list for over five 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."
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Photo: Benzinga edit with photo by qimono on Pixabay and Doc James on Wikimedia Commons.