ALBAWABA - An unexpected setback to the burgeoning effort to bring psychedelics out of the shadows as a new therapeutic option for post-traumatic stress disorder (PTSD) was handed down as the US FDA rejected a proposal to allow Lykos Therapeutics' MDMA-based medication to be used in conjunction with talk therapy.
MDMA, frequently referred to as ecstasy or molly, has been promoted in several medical circles as a therapeutic aid for patients with various mental health conditions. But according to the medicine manufacturer, the US Food and medicine Administration rejected authorizing the drug due to concerns regarding the shortage of clinical evidence and whether or not psychotherapy genuinely improves treatment outcomes.
For many years, psychoactive substances including MDMA, LSD, and psilocybin have been outlawed. However, academic investigations exploring their potential applications in diverse domains are gradually gaining traction in the hope of broadening accessibility outside strictly restricted research settings, as reported by Vox.
Developing psychedelics as medical remedies for a wide variety of prevalent but difficult-to-treat illnesses, such as chronic pain and anxiety and depression, has shown to be one of the most promising avenues for psychedelics.
Amy Emerson, CEO of Lykos Therapeutics, commented in a statement “the FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades.”
In accordance with the Controlled Substances Act, the substance is currently classified as Schedule I, joining heroin and cannabis in that category of drugs described as those that "have no currently accepted medical use and a high potential for abuse."
