PharmaTher Holdings Pursues Ketamine-Based Medical Product, Eyes Global Market After FDA Nod

LOS ANGELES- In a recent development marking a leap in the medical application of ketamine, PharmaTher Holdings announced that the U.S. Food and Drug Administration (FDA) accepted the Abbreviated New Drug Application (ANDA) for its KETARX ketamine product. The target date for this priority original ANDA, under the 2022 Generic Drug User Fee Amendments (GDUFA), is set for April 29, 2024. This progress further solidifies PharmaTher’s intentions to roll out KETARX in the U.S. and eventually tap into the global market.

The innovative KETARX Ketamine Patch by PharmaTher is engineered for intradermal delivery. It’s designed to aid a spectrum of mental health, neurological, and pain disorders. The product features hydrogel-forming microneedle arrays, coupled with a reservoir, thereby circumventing the restrictions posed by drug quantities loaded into the needles.

Ketamine, a fundamental anesthetic and pain relief medicine, holds a spot on the WHO Essential Medicines List. Despite its critical role, it has found a place on the FDA’s drug shortage list since February 2018. Furthermore, Canada designated it as a Tier 3 drug shortage in February 2023, although Health Canada has approved its use in hospitals for sedation and pain management.

The scope of ketamine is widening, with medical professionals increasingly using it for an array of mental health, neurological, and pain disorders. Contemporary research underscores the effectiveness of intravenous ketamine therapy, especially in patients grappling with depression, anxiety, and suicidal thoughts.

This expansion in the usage of ketamine products came under the spotlight with Johnson & Johnson’s fiscal report in July. Their drug, Spravato, primarily for treatment-resistant depression, exhibited impressive sales growth. Spravato employs esketamine, a nasal spray derivative of ketamine.

With its immediate vision centered on the U.S. market, PharmaTher unveiled its alliance with Vitruvias Therapeutics, Inc., a significant U.S. generic pharmaceutical player. The roadmap includes introducing diverse formulations of ketamine across domestic and international territories, with a focus on ready-to-use applications.

This move by PharmaTher is reflective of the evolving therapeutic landscape, where the integration of previously sidelined drugs like ketamine is carving a new path in patient care.