A drugmaker behind an MDMA treatment said the FDA notified the company its drug “could not be approved based on data submitted to date” and requested an additional study.
Drugmaker Lykos Therapeutics said the FDA notified the company that its drug “could not be approved based on data submitted to date,” and requested an additional late-stage study. Such studies generally takes several years and millions of dollars to conduct. The company said it plans to ask the agency to reconsider.
Lykos said the issues FDA raised in what’s called a complete response letter echoed the concerns during the June meeting. In recent years, MDMA research has been widely publicized by combat veterans, who say the lack of treatments options for the condition has contributed to higher rates of suicide among military personnel. Last month, veterans supporting psychedelic therapy rallied on Capitol Hill in support of the drug. And more than 80 House and Senate lawmakers have signed letters to the FDA in recent weeks urging MDMA’s approval.
Canada Latest News, Canada Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA won't approve psychedelic MDMA for PTSD, calling for additional studyWASHINGTON (AP) — Federal health regulators on Friday declined to approve the psychedelic drug MDMA as a therapy for PTSD, a major setback for groups seeking...
Read more »
FDA won't approve psychedelic MDMA for PTSD, calling for additional studyWASHINGTON (AP) — Federal health regulators on Friday declined to approve the psychedelic drug MDMA as a therapy for PTSD, a major setback for groups seeking a breakthrough decision in favor of using mind-altering substances to treat serious mental h
Read more »
Veterans lobbied for psychedelic therapy, but it may not be enough to save MDMA drug applicationNEW YORK (AP) — It was a landmark moment for the psychedelic movement : The Department of Veteran Affairs’ top doctor stood on stage, praising advocates who have spent decades promoting the healing potential of mind-altering drugs .
Read more »
21YO Self-Diagnoses PTSD After Friends Don’t Remind Her About An Upcoming PartyWoman claims she was 'traumatized' when friends forgot to call her, poster snapped at her for using psychological terms without knowing their meanings.
Read more »
FDA approves first nasal spray to treat dangerous allergic reactionsWASHINGTON (AP) — U.S. health officials on Friday approved the first nasal spray to treat severe allergic reactions, offering an alternative to injectable...
Read more »
FDA approves Guardant Health's blood test for colon cancerShares of Guardant Health (GH) rose after the US Food and Drug Administration approved the company's blood test to screen for colorectal cancer in some...
Read more »