Lykos reorganizes after midomafetamine setback

US hallucinogenic medicines developer Lykos Therapeutics has announced a reorganization to best support the company as it works to address the resubmission of its new drug application (NDA) for midomafetamine capsules for the treatment of post-traumatic stress disorder (PTSD) in adults.

The decision follows a setback for the company, as the US Food and Drug Administration (FDA) earlier this week issued a complete response letter (CRL) on the new drug application (NDA) for midomafetamine capsules for the treatment of post-traumatic stress disorder (PTSD) in adults,

"Lykos is deeply dedicated to bringing midomafetamine to those suffering from PTSD and remains highly committed to this goal," said Jeff George, chairman of the Lykos board. "At the same time, we take to heart the FDA's decision and the additional work we will need to do to bring this pioneering therapy to market," he noted.