After the FDA rejected its proposed MDMA treatment, Lykos Therapeutics is laying off 75 percent of its staff and its founder has left the company.
For a while, it looked like the psychedelic drug MDMA was poised to become an approved treatment for post-traumatic stress disorder. Now, after being rejected by the US Food and Drug Administration, MDMA faces an uphill battle to becoming legalized as medicine. In 2017, the FDA granted MDMA “breakthrough therapy” status, a designation that recognizes a new drug’s potential benefits and expedites its review.
“Once you have an unblinded trial, you potentially have all kinds of questions about efficacy,” says David Rind, chief medical officer of the Boston-based nonprofit Institute for Clinical and Economic Review, which published a report in May raising concerns about the validity of the Lykos trial data. Blinded trials with a placebo group are often considered the gold standard in medical research, but Rind says there are other ways to ensure reliable results.
Health Mental Health Medicine Drugs Psychedelic
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