More than a dozen companies are racing to win FDA approval for ketamine-based mental health treatments. Providers warn that one company’s bid could sharply raise the cost of the generic drug, while most of the new products are designed to skip the talk therapy many clinicians consider essential, The New York Times reported Oct. 20.
The companies are developing new formulations and combinations of ketamine, a generic anesthetic increasingly used off-label for depression and other mental health conditions. Johnson & Johnson’s Spravato, a ketamine-like nasal spray, is the only FDA-approved psychedelic treatment on the market.
Here are five things to know:
1. NRx Pharmaceuticals has submitted an FDA application for Ketafree, a preservative-free formulation of ketamine packaged in a specialized vial that stays sterile without a preservative. NRx expects an FDA decision in early November, according to its CEO, Jonathan C. Javitt, MD. The company said its application was progressing quickly and that it had ordered 5 million doses in anticipation of commercialization. NRx has not disclosed its planned pricing.
2. NRx separately petitioned the FDA to ban the nation’s existing ketamine supply, nearly all of which contains the preservative benzethonium chloride, claiming the preservative poses health risks. Dr. Javitt acknowledged a lack of data linking the preservative in ketamine to harm in humans, according to the Times. Critics noted it has been used in drugs for more than 50 years without reported problems.
3. Healthcare providers are concerned about potential price increases. Critics say NRx’s bid to corner the $750 million ketamine market could upend anesthesia and psychedelic medicine by dramatically raising the drug’s cost. Generic ketamine costs roughly $1 per dose and already experiences intermittent shortages.
4. Several other drugmakers are developing ketamine-based treatments, though none has yet won FDA approval. Solvonis Therapeutics is seeking approval for an oral film to treat alcohol use disorder. Freedom Biosciences is developing a treatment that combines ketamine with a kidney cancer drug to extend ketamine’s antidepressant effects. Tasman Therapeutics is working on an extended-release oral formulation for depression that could be taken at home. Nearly all of the new ketamine drugs are designed to be administered without talk therapy, which some providers worry will weaken their therapeutic benefits.
5. Johnson & Johnson is expected to earn $2.3 billion from Spravato this year. Insurers pay as much as $1,200 per session, which covers the nasal spray and a mandated two-hour observation period. Spravato is approved only for patients with major depressive disorder who have not responded to at least two oral antidepressants or who have suicidal thoughts.
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