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# FDA Asked to Drop Clinical Hold on Party Drug
- URL: https://www.fdaweb.com/fda-asked-to-drop-clinical-hold-on-party-drug/
- Published: 2021-05-10T12:00:00.000Z
- Updated: 2026-09-14T16:58:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149283

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](https://mapscontent.s3-us-west-1.amazonaws.com/pdfs/12%5F2021.04.16+-+MT2+MDMA+Dispute+Appeal+Granted%5FRedacted.pdf?ref=fdaweb.com) 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).