In addition to its Phase III assessment as a treatment for individual sufferers of PTSD, MDMA is under evaluation as a potential treatment for couples therapy, eating disorders, alcohol addiction, anxiety and depression.
Currently, there is a global shortage of MDMA to sustain clinical research. While MDMA is an off- patent molecule, the process development and regulatory burden for the manufacturing of a controlled substance have significantly narrowed the number of manufacturers.
Of the many and numerous chemicals considered ‘illicit drugs’, MDMA has perhaps the most interesting clinical past. In the 1970s, it was quietly used as a psychotherapeutic drug, with some psychiatrists considering it to improve communication with patients, reportedly allowing users to achieve greater insights into their problems.
In the 1980s MDMA became established as a popular dance drug due to its mood-enhancing properties, primarily the ‘3 E’s’: Energy, Empathy and Euphoria . In 1985, following public outcry about the recreational use of the drug, the methyl-enedioxy and methoxy derivatives of the amphetamines were placed in Schedule 1 of the restricted drugs list in the United States and they are classified similarly in Canada (Schedule III of the Controlled Drugs and
Substances Act) and the United Kingdom (Class A under the Misuse of Drugs Act). However, this was not without significant attempts by the psychiatric profession to protect the clinical availability of what they considered to be an important, and perhaps life- saving treatment.
Though that attempt failed, researchers and scientists remain involved in advocating for the use of MDMA, the largest and most influential group being MAPS. MAPS was founded in 1986 as a direct result of the FDA’s banning of MDMA. Since then, MAPS has collected millions of dollars in donations, and has contributed millions of dollars to scientific research into MDMA, cannabis and other psychedelic chemicals with therapeutic potential. It is largely thanks to their advocacy and funding that as much is known about the therapeutic potential of MDMA.
Treatment of mental health disorders remains a difficult task. Lack of focus and funding has compounded this. Psychedelic drugs, especially when combined with psychotherapy provided by an accredited and trained therapist, offers one possible solution.
Spring-boarding off anecdotal and clinical reports from the golden era of psychedelic experimentation from the 1970’s and early 1980’s, in the past two years the US FDA has approved ketamine for treatment-resistant depression and has approved MDMA and psilocybin for the breakthrough therapy designation.
Interestingly, though these three chemicals are often grouped together as ‘hallucinogens’ their pharmacological effects are quite different. Ketamine is a dissociative anaesthetic, which acts on the glutaminergic system, psilocybin could be considered a more classical ‘psychedelic’ as it works primarily through binding to the 5-HT receptor (3–5) whereas MDMA is an ‘entactogen’ working primarily through serotonin norepinephrine and dopamine transporters (6–10).
PharmAla works with established, best-in-class laboratories across Canada to develop novel processes for the manufacturing of MDMA and other MDXX substances. We hold ourselves to the highest standards of compliance and rigour in our manufacturing processes. Our Research and Development team is engaged in preclinical research on 2 of our novel chemical entities, with the goal of increasing the safety of MDMA and its analogs.