Canadian firms to release GMP-compliant MDMA capsules for clinical trials worldwide
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Canadian pharmaceutical firms PharmAla Biotech Holdings and Filament Health Corp have announced the release of their GMP-compliant MDMA capsules for purposes of clinical trials and for use in authorized patients across the globe. MDMA is the acronym for 3,4-methylenedioxy-methamphetamine, a synthetic drug that became popular by its street name, Ecstasy.
Until a few years ago, Ecstasy, also known by other names such as molly or mandy, was primarily used for recreational purposes. However, the lack of new drug interventions in the field of psychiatry and the side effects of existing drugs have meant that psychedelics are being considered a potential treatment option.
To facilitate the quickened research in this direction, the U.S. Food and Drug Administration (FDA) has awarded MDMA and psilocybin – a compound naturally produced by fungi, 'breakthrough' status.
GMP-compliant MDMA
Since MDMA has been abused as a recreational drug, it is placed under the "most restrictive category" of drugs by Drug Enforcement Administration. With the shifting trends in the pharmaceutical industry, the regulatory landscape needs to change and allow the drug to be used for trials and treatments.
While MDMA has previously been synthesized in a non-controlled environment, GMP-compliant MDMA ensures that the same drug is made under conditions supervised by technical experts in an environment that is suitable for the manufacturing of drugs. The drug is extensively tested for its nature and purity before being released to patients or for trials.
MDMA has also shown potential for the treatment of post-traumatic stress disorder (PTSD), among other mental health conditions. The two Canadian firms are looking to fulfill the growing demand for GMP-compliant MDMA as more centers look to carry out clinical trials and make the drug available for authorized patients. The companies are currently looking to supply these capsules in Canada and Australia, to begin with, but are looking to scale up distribution across the globe.
However, the companies are not alone. The use of psychedelics as valid treatment options is the new buzz in Silicon Valley, with more than $560 million of venture capital funds having been invested in companies and related services.
Sam Altman, the CEO of OpenAI, which is pushing the boundaries of what AI can do, is also pushing for the use of psychedelics for mental healthcare and addiction treatments. His startup Journey Colab is working with a rehab clinic to take psychedelics through late-stage clinical trials and design a model for administering them to patients, The Washington Post reported.
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