PharmAla Biotech Holdings Inc., the only manufacturer and exporter of clinical-grade MDMA in the world, has signed a sales agreement with Australian drug developer Emyria Limited for its patented MDMA LaNeo. This comes after Australia announced on February 3rd that it will allow psychiatrists to prescribe MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression starting from July. PharmAla Biotech’s COO, Shane Morris, said that the company has an opportunity to build “one of the preeminent psychedelics operations in Australia”. PharmAla Biotech’s drug API is GMP-certified and is available to companies or people who have permission to use it for research or as an exception. The company can also export it to be used by clinical trial practitioners globally, subject to the issuance of import and export permits.
PharmAla Biotech’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules. The company’s CEO, Nick Kadysh, said that it has already been running three different clinical trials for its LaNeo MDMA molecule and is committed to responsibly supplying its customers as they develop operational capacity.
Other companies have also started to look at importing MDMA and psilocybin into Australia following the regulatory changes. Creso Pharma’s subsidiary, Halucenex Life Sciences, is currently running a Phase II clinical trial to test psilocybin as a treatment for PTSD and may register its synthetic psilocybin formulation for the Australian market. Vancouver-based Optimi Health has submitted a clinical trial application after successfully producing the first batch of its patented MDMA variety OPTI-MHCL.
The changes in Australian regulations have opened up opportunities for these companies to supply their clinical operations. These developments indicate a growing interest in psychedelic drugs as potential treatments for mental health disorders.
