FDA Holds Back MDMA Psychedelic Therapy Over Safety, Efficacy Concerns

A company seek to treat post - traumatic stress disorderliness with a combining of MDMA and lecture therapy just suffered a major setback from the U.S. Food and Drug Administration .

Lykos Therapeutics , the business firm aiming for FDA favorable reception , said on Friday that itreceived a rejection letterfrom the authority , which called for more enquiry into the possible treatment ’s guard and efficacy . Lykos said in response that it want the FDA to reconsider the decision , adding that it will request a merging to “ further talk over the agency ’s recommendation for a resubmission . ” MDMA , also known as molly and ecstasy , is a lab - made drug developed more than a one C ago by a pill roller at the German pharmaceutical giant Merck .

The decision follows an earlier vote from FDA advisors , whorejected the MDMA - assisted therapy in June . The instrument panel questioned the treatment ’s long - term efficacy and safe , the character of Lykos ’ data , and theconduct of healer who participated in earlier Lykos studies . While the FDA had the option to represent against its jury ’s feedback , the authority reportedly reached a similar conclusion .

A close-up of the United States Food and Drug

A close-up of the United States Food and Drug Administration’s logo. © Jeppe Gustafsson / Shutterstock

According to Lykos CEO Amy Emerson , comport a third form 3 trial run would set up the house back several years . Calling the FDA ’s letter “ deeply disappointing , ” Emerson argued in a financial statement that the agency ’s requests “ can be addressed with exist information , post - approval demand or through reference to the scientific literature . ”

Lykos did not bring out the rejection alphabetic character , and the FDA did not immediately respond to Gizmodo ’s asking for more info . However , a voice for the delegacy toldNPRon Friday , “ there are significant limitations to the datum check in the applications programme that prevent the agency from concluding that this drug is good and effective for the suggest indication . ”

The spokesperson added that the agency “ will go along to encourage inquiry and drug growth that will further design for psychedelic treatments and other therapies . ”

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