In 2018, the FDA gave breakthrough status to COMP360 for treatment-resistant depression. The company is evaluating COMP360, paired with therapy, in a Phase 2b trial for that condition.
Still, regulatory approval could still be far off. Researchers face questions about patentability and profitability, as well as standardizing therapy and figuring out its most effective form. Currently, therapists pair psychotherapy with ketamine. However, they administer the drug off-label or for a use that hasn’t been approved by regulators therefore insurance won’t cover the medication itself.
Last year, the FDA approved the Johnson & Johnson (NYSE: JNJ) drug Spravato, which uses a derivative of ketamine for treatment-resistant depression. This summer, the FDA approved Spravato for people who are actively suicidal.
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