Pharmaceutical drug developer PharmaTher Holdings further advanced its ketamine-based medical product ambitions with a noteworthy announcement today. The U.S. Food and Drug Administration (FDA) has officially accepted the Abbreviated New Drug Application (ANDA) for KETARX, a racemic ketamine product, for review. The FDA has set a target date for this priority original ANDA under the Generic Drug User Fee Amendments of 2022 (GDUFA) for April 29, 2024. Following this regulatory milestone, PharmaTher plans to launch KETARX in the U.S. and subsequently pursue approvals on a global scale to meet the increasing demand for ketamine.
The acceptance of the ANDA for ketamine is a significant milestone for PharmaTher that brings us one step closer to becoming a global leader in ketamine for unmet medical needs. 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.”
Fabio Chianelli, CEO of PharmaTher
The PharmaTher KETARX Ketamine Patch aims to deliver ketamine for intradermal administration to treat various mental health, neurological and pain disorders. It consists of hydrogel-forming microneedle arrays and an accompanying reservoir that will overcome limitations by the quantity of drug loaded into the needles or onto the needle surfaces.
Ketamine holds essential status as a medicine for anesthesia and pain relief and is recognized on the WHO Essential Medicines List. However, it has been listed on the FDA’s drug shortage roster since February 2018. In Canada, it has been designated as a Tier 3 drug shortage since February 2023, and Health Canada has granted approval for ketamine’s use as a sedative and painkiller in hospital settings.
Beyond the approved indications by the FDA and Health Canada, ketamine is increasingly being administered in medical facilities to address a range of mental health, neurological, and pain-related disorders. Recent peer-reviewed research has highlighted the real-world effectiveness of intravenous ketamine therapy, showing substantial improvements in patients with depression, anxiety, and suicidal ideation.
The rapid pace of real-world uptake of ketamine derivative products came to light in July, when global pharmaceutical behemoth Johnson & Johnson (NYSE: JNJ) announced results for their fiscal second quarter 2023. While he company handily surpassed analyst forecasts with strong performance across most operating divisions, Spravato sales growth was particularly noteworthy.
Spravato is an FDA-approved drug developed and manufactured by Johnson & Johnson. The drug is designed to treat adults with treatment-resistant depression, a severe form of depression that does not respond adequately to other available treatments. Its active ingredient is esketamine, which is a nasal spray derivative formulation of a dissociative anesthetic, ketamine.
PharmaTher’s immediate focus is on introducing KETARX to the U.S. market through its recently revealed partnership with Vitruvias Therapeutics, Inc., a prominent U.S.-based specialty generic pharmaceutical company. The company’s plans include marketing various forms and concentrations of its ketamine formulation for both U.S. and international markets, with the option to provide ready-to-administer applications.