While Big Pharma has yet to embrace psychedelics as potential treatments for depression and other psychiatric disorders, interest in psychedelic medicine is building.
Earlier this month, Nature Medicine published a Phase 3 study indicating that psychotherapy assisted with methylenedioxymethamphetamine (MDMA) was a more effective treatment for post-traumatic stress disorder (PTSD) than therapy alone. The study authors concluded that MDMA yielded a larger effect size than antidepressants Zoloft (sertraline) and Paxil (paroxetine).
The FDA granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD in 2017. Approval could come in 2023, according to The New York Times.
Last month, NEJM summarized the results of a Phase 2 study that found that psilocybin was superior to escitalopram (Lexapro) in treating depression.
Johnson & Johnson (NYSE:JNJ) scored an FDA approval for its ketamine-related Spravato for treatment-resistant depression.
Many mental health experts, however, still have reservations about using traditional psychedelics to treat psychiatric disorders. The possibility of prescription psychedelics could fuel illicit use of those drugs. Such is the case for drugs such as Adderall and Ritalin used to treat attention-deficit/hyperactivity disorder (ADHD).
The U.S. Drug Enforcement Administration labels most psychedelics as Schedule 1 or 2 drugs, making their use illegal outside of clinical research.
Still, interest from (predominately small) pharmaceutical companies in psychedelics is building.
MindMed (NSDQ:MNMD) recently announced it is launching a trial to explore the therapeutic potential of mescaline after receiving approval from a Swiss ethics committee.
Cybin (OTCMKTS: CLXPF) is launching a Phase 2 clinical study to test a sublingual formulation of psilocybin for people with major depressive disorder.
Kelowna, Canada–based Tryp Therapeutics (CNSX:TRYP) is currently doing preclinical research on psilocybin for fibromyalgia, eating disorders and chronic pain.
Privately-held Cognistx (Pittsburgh) and MagicMed (Calgary, Canada) are partnering to develop an AI platform to facilitate research on psychedelic-derived pharmaceuticals.
Still, it remains to be determined whether psychedelics will disrupt the psychotropic drug market or whether the growing investment in the space will turn out to be a bad trip.
Filed Under: clinical trials, Drug Discovery, Psychiatric/psychotropic drugs