FDA Asked to Drop Clinical Hold on Party Drug

After winning an appeal at FDA last month to remove clinical trial requirements that led to a clinical hold on a study designed to assess the psychological effects of MDMA-assisted psychotherapy, the Multidisciplinary Association for Psychedelic Studies (MAPS) has formally requested that the agency remove the hold. MDMA is a party drug known as Ecstasy or Molly.

Last month, CDER Office of Neuroscience (OON) granted the appeal that removed restrictions imposed by the office’s Division of Psychiatry. OON deputy director Eric Bastings basically agreed with the arguments submitted by MAPS in response to the partial clinical hold issues. The appeal decision specifically notes that Study MT2 does not carry a more unfavorable benefit/risk ratio than prior studies and that clinical investigator requirements should not be held to a different standard than prior approved studies (Study MT1).