Psychedelics

Psychedelics derived from plants and fungi have been used since ancient times for religious and medicinal use.  They are a diverse group of hallucinogens which alter awareness, mood, and emotions.  Early research has indicated that hallucinogens affect brain chemistry and signaling and may affect serotonin, which in turn, can affect sleep, hunger, sensory perception, and mood.

There are 2 types of hallucinogens: classic (e.g., LSD, psilocybin, DMT) and dissociative (e.g., PCP, ketamine, and dextromethorphan).  Naturally derived and synthetic forms of both types of hallucinogens are currently being explored as therapeutics for depression, anxiety, alcohol and nicotine addiction, OCD, and obesity.

Despite the long history of human use of hallucinogens, there is surprisingly little controlled clinical research to aid in our understanding of the benefits and risks of psychedelics for the treatment of CNS disorders.

Facet is proud to be a leading regulatory development partner in helping organizations progress their psychedelic therapeutic products as drugs in the US.
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Special Topic: Lykos MDMA Advisory Committee Meeting

On June 4, 2024 the FDA held a much awaited advisory committee meeting to discuss the NDA submitted by Lykos Therapeutics for their MDMA product for the treatment of post-traumatic stress disorder (PTSD).  This is the first psychedelic therapeutic product under consideration by the FDA.  The FDA highlighted several concerning flaws in the design and conduct of the clinical studies supporting the application.  In particular, the Agency raised concerns over functional unblinding during the studies because the vast majority of participants were able to correctly guess whether they received active or placebo.  There were also alleged cases of misconduct at some of the clinical sites that included allegations of sexual assault on participants while they were under the effects of the product.  Ultimately the advisory committee voted unanimously that the FDA should not approve the product at this time.  On August 9, Lykos announced that they received a complete response letter (CRL) for their NDA.  The CRL reportedly outlined many of the issues identified in the advisory committee meeting.  Further, FDA requested that Lykos conduct an additional pivotal efficacy and safety trial.  In yet more bad news for the company the week following the CRL, several noteworthy medical journals retracted articles that present trial results based on concerns of trial misconduct. 

“Facet helped our team achieve something unheard of in the psychedelics industry.  Their strategic leadership and flawless tactical execution supported us from conception to successful IND-filing for a new chemical entity in 18 months.”

Michael Palfreyman, Ph.D., Cybin

Facet has experience:

  • Designing streamlined nonclinical programs for naturally derived and synthetic psychedelics to speed opening a research or commercial IND
  • Evaluating IND- and NDA-stage development programs for gaps and risks to clearance/approval
  • Conducting literature searches and reviews of publicly available data to propel regulated development
  • Providing strategic guidance and support to help satisfy FDA’s chemistry, manufacturing, and controls (CMC) requirements for naturally derived and synthetic psychedelics
  • Championing the preparation, submission, and maintenance of INDs and NDAs
  • Working effectively with FDA Office of Neuroscience – Division of Psychiatry and Neurology I and II