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Post: MDMA-Assisted Therapy Receives a Complete Response Letter from the FDA

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MDMA-Assisted Therapy Receives a Complete Response Letter from the FDA
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Feature

Article

August 9, 2024

Author(s):

Giuliana Grossi

Today, the FDA issued a complete response letter (CRL) for midomafetamine capsules (MDMA) in combination with assisted therapy (MDMA-AT) for adults living with posttraumatic stress disorder (PTSD) . 1

Upon completion of its review, the FDA stated that it could not approve the treatment based on the data submitted and suggested Lykos Therapeutics conduct an additional phase 3 study to expand on the efficacy and safety profile. Image Credit: Svitlana – stock.adobe.com Lykos Therapeutics is planning to meet with the FDA to request "reconsideration of the decision and to further discuss the agency’s recommendations for a resubmission seeking regulatory approval for midomafetamine capsules," according to the statement .

"The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades," Amy Emerson, chief executive officer of Lykos Therapeutics stated. "While conducting another phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the advisory committee meeting can be addressed with existing data, post-approval requirements, or through reference to the scientific literature."

Data from a pair of phase 3 studies submitted by Lykos demonstrated MDMA-AT significantly reduced PTSD symptoms among participants who received the treatment compared with those in the placebo group. The primary outcome was measured by a reduction in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score from baseline to 18 weeks.Just last week Lykos announced new initiatives and measures for additional oversight for the treatment of adults with PTSD using MDMA-AT. 2 PTSD continues to be a significant public health challenge. About 6% of people in the US (8% of women, 4% of men) will have PTSD at some point in their lifetime, according to estimates from the National Center for PTSD . 3 However, the consequence of PTSD translates into crisis among the veteran population. While rates of veteran suicide […]

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