Psychedelic company Cybin Inc., has recruited a former Food and Drug Administration (FDA) division director to help the company navigate the long and winding regulatory process as it prepares to enter clinical trials for its sublingual formation of psilocybin for patients with major depressive disorder. Dr. Thomas Laughren, a medical director who headed up the FDA’s division of psychiatry products for nearly 30 years, will take a post on Cybin’s clinical advisory board.
In his role with the FDA, Laughren was charged with overseeing the review of all psychiatric drug development activities for Investigational New Drugs (IND) and the review of all New Drug Applications (NDA) and supplements for new psychiatric drug applications. He left the agency in 2012 to work as a consultant helping psychedelic pharmaceutical developers obtain FDA approval.
“As we study psychedelic medicines, the regulatory pathway ahead is still coming into focus. There are outstanding questions to be addressed as to how psychedelic treatments may be considered for approval in therapeutic contexts. Dr. Laughren is familiar with these potential challenges, and he brings extensive psychiatric regulatory and development expertise. We are excited to welcome Dr. Laughren to Cybin’s Clinical Advisory Board to provide guidance as we develop our regulatory strategies,” Cybin’s Chief Clinical Officer Dr. Alex Belser said in a news release.
Cybin is on track to launch a Phase-2 clinical trial to study its sublingual formulation of psilocybin for patients with major depressive disorder. The study will be held at the University of West Indies Hospital in Jamaica, where the psychedelic compound is legal. Psilocybin, the psychoactive ingredient in magic mushrooms, has been found in previous studies to be effective at treating symptoms of depression. Cybin’s formulation is designed to provide rapid absorption and faster onset with a shorter duration of psychedelic experience.
