Lykos Therapeutics faced a setback in August as the Food and Drug Administration (FDA) rejected its application for MDMA-assisted therapy as a treatment for post-traumatic stress disorder (PTSD). Despite promising results from clinical trials, regulators cited concerns over the data, particularly regarding the role of psychotherapy in the treatment's efficacy.
The clinical trials showed that 71% of participants reported improvement with MDMA-assisted therapy. However, the FDA was hesitant to approve the treatment, leading to a request for more data. Bruce Poulter, a researcher with the Multidisciplinary Association for Psychedelic Studies (MAPS), indicated that another clinical trial is being planned. This development could delay the potential approval of MDMA-assisted therapy by three to four years.
"It’s completely heartbreaking that we’re not able to offer [this] right now," Poulter stated, highlighting the disappointment felt by therapists and patients who were hopeful about the treatment's potential.
In Boulder, Colorado, concerns have been raised regarding high-potency cannabis products. Anxious parents and healthcare providers asked Boulder’s Cannabis Licensing and Advisory Board (CLAB) to ban marijuana concentrates and put mandatory warnings on high-potency THC products, worried about the potential impacts to young people’s mental and physical health. The cannabis industry is strongly opposed to a ban on concentrates, which make up more than a third of all marijuana sales in Colorado.
