The U.S. Food and Drug Administration released an analysis Friday that raised extensive questions about the benefits of treating post-traumatic stress disorder with MDMA-assisted therapy, which aims to be theLykos Therapeutics, which conducted two late-stage clinical trials showing that patients treated with MDMA — better known by its street name, ecstasy — experienced a significant improvement in their PTSD symptoms relative to those who got a placebo.
Lykos CEO Amy Emerson said the company — formerly known as MAPS Public Benefit Corp. — stands by the quality and integrity of its research and development. “Given there has not been a new PTSD medication approved in the United States in over two decades for the 13 million people living with PTSD, we are deeply committed to making a difference by bringing a potential new treatment to patients,” she said in a statement.
Lykos also conducted a follow-up study to determine how long the benefits of its treatment lasted, and the data showed a durable effect: Participants who got the MDMA fared better than those who got the placebo more than six months later. Such restrictions would also include a patient registry to track negative physical and mental effects. The agency said it is considering the requirement of a post-approval study to gauge the safety risk of MDMA.Lykos, in its submission ahead of the meeting, acknowledged it was working with the FDA on restrictions, which could also include packaging of single doses only and oversight of distribution by the DEA.
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