NRx Pharmaceuticals and Nephron Pharmaceuticals have come together in a bid to develop the first FDA-approved intravenous ketamine treatment for suicidal depression.
The partnership will see NRx developing the drug while giving Nephron the responsibility of manufacturing the product. As per chief scientist and director Dr. Jonathan Javitt, NRx aims to deliver a two-year shelf-stable ketamine formulation to patients by November 2024.
Nephron is in the process of setting the stage for submitting an New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the drug. The target deadline for filing the application is 1 March, 2024, said Nephron CEO Lou Kennedy.
According to the US Centers for Disease Control and Prevention (CDC), suicide rates have risen by approximately 36% from 2000-2021, with suicide being the second leading cause of death in 2021 for individuals in the age groups of 10 –14 years and 20 –34 years.
Kennedy suggested that in tackling development of single-dose intravenous ketamine, the partnership will address an unmet need for depression. “There are few efforts as important as playing a role—through research and development—in tackling the nation’s mental health crisis,” explained Kennedy.
For years, ketamine has been hailed for its antidepressant capability and has been used by caregivers to treat neurological disorders outside of FDA-approved indications. This led the FDA to issue a warning emphasising that the drug is not approved by the agency, in October.
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While there is currently no FDA-approved ketamine drug for suicidal depression, there are, however, other antidepressants and adjunctive antidepressant treatments on the market and in development.
Janssen’s Spravato (esketamine), a chemically similar drug to ketamine, was first FDA-approved as a nasal spray for treatment-resistant major depressive disorder (MDD) in 2019, and later to treat MDD patients with suicidal ideation in 2020.
PharmaTher, whose drug Ketarx (racemic ketamine) is currently being used off-label for the treatment of mental health, neurological, and pain disorders, plans to secure FDA new drug approval for Ketarx in Q1 2024 and commercially launch the drug for levodopa-induced dyskinesia in Parkinson’s disease (“LID-PD”) in Q2 2024.
Also looking to secure its share of the antidepressant market, Gates Neurosciences told Pharmaceutical Technology in May, its plans to initiate a Phase II MDD study for NMDA receptor modulator zelquistinel in Q4 2023.
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