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On Friday, the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Lykos Therapeutics for its groundbreaking MDMA-assisted therapy to treat PTSD. MDMA, better known as ecstasy, is a synthetic hallucinogenic substance that is currently listed as a Schedule I substance under the Controlled Substances Act. The issuance of a CRL is the FDA’s mechanism to advise pharmaceutical companies that a drug therapy has been rejected. A CRL does not necessarily mean the end of the therapy’s development, rather a CRL points out the issues or concerns that the FDA identified during its review. Lykos, like any company seeking FDA approval that receives a CRL, is permitted to continue development to address the FDA’s concerns. While a CRL is rarely made public, Lykos did make a public statement that perhaps sheds some light on some of the concerns identified by the FDA. Lykos’ statement can be found at the link below.
Read the Statement by Lykos Therapeutics Statement on FDA Advisory Committee Meeting
