Nightmare blow for Lykos’ ecstasy dream
Lykos Therapeutics’ hopes of being the first to market with a hallucinogenic medicine suffered a major blow Tuesday during a meeting of the US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC).
The panel discussed the company's new drug application (NDA) for midomafetamine (MDMA) capsules, used in combination with psychological intervention (MDMA-assisted therapy), for the treatment of post-traumatic stress disorder (PTSD) in adults.
"We are disappointed in today's vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment"The PDAC voted by an overwhelming nine votes to two against the notion that the available data show that MDMA is effective in patients with PTSD.
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