How can regulators judge the efficacy and safety of a product that makes patients feel so good, so quickly, that trial blinding is impossible, and the drug’s positive effects may carry abuse potential?

That’s what the FDA’s Psychopharmacologic Drugs Advisory Committee will wrestle with when they dive into the supporting data for midomafetamine (MDMA), Lykos’ potentially paradigm-shifting post-traumatic stress disorder treatment.

An approval here would be a first-in-class, and an important step in the burgeoning field of psychedelic therapeutics for mental disorders. But MDMA alters mood and perception so drastically that, the FDA said, it was hard to tease out how much of the improvement was due to the MDMA itself — not the additional therapy that both groups receive — and that safety signals might have been masked. Blinding was virtually impossible, too, which could have introduced both positive and negative bias, the agency said.

Read the briefing document here.

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