PharmAla Responds to USFDA MDMA Therapy Decision, Announces ALA-002 Patent

PharmAla Biotech Holdings Inc. (PharmAla), a biotechnology company specializing in the research, development, and production of LaNeo™ MDMA and novel MDXX class molecules, has expressed its disappointment with the recent decision by the US Food and Drug Administration (USFDA). The USFDA has requested that Lykos Therapeutics conduct a third confirmatory Phase 3 trial before approving MDMA-assisted therapy (MDMA-AT) for treating Post-Traumatic Stress Disorder (PTSD).

According to Nicholas Kadysh, CEO of PharmAla, this decision will have limited immediate impact on PharmAla’s operations since the company does not operate in the US except as a supplier for clinical trials. He acknowledged the FDA's responsibility to ensure safety and effectiveness but emphasized the urgent need for innovative PTSD treatments. Kadysh pointed out that MDMA has a substantial base of published clinical research supporting its use and is currently being utilized in patient treatments in Canada and Australia, with PharmAla as the supplier. He emphasized the need for continued research to convince even the most skeptical regulators of the safety and efficacy of MDMA.

PharmAla manufactures LaNeo MDMA capsules in Canada under Good Manufacturing Practice (GMP) conditions. These capsules are distributed under the Health Canada Special Access Program to qualified patients and in Australia under the Therapeutic Goods Administration (TGA)’s Authorized Prescriber Scheme. In Australia, the distribution and sales are managed by Cortexa, a joint venture between PharmAla and Vitura Ltd.

Dr. Shane Morris, COO of PharmAla, expressed optimism that the FDA's decision would lead to an increase in clinical research on MDMA. PharmAla is a key supplier of MDMA for such research, with over a dozen human clinical trials contracted worldwide. The company plans to continue supporting its partners in their research endeavors.

In other news, PharmAla announced that the US Patent and Trademark Office (USPTO) has issued a patent for its novel, non-racemic mixture of MDMA enantiomers, internally referred to as ALA-002, under patent No. 12,053,452. Dr. Harpreet Kaur, VP of Research at PharmAla, stated that this patent is a significant milestone for the company’s research and development efforts. Kaur noted that there have been concerns regarding certain aspects of racemic MDMA, including acute and chronic cardiotoxicology and adverse events like hyperthermia. PharmAla's preclinical research has addressed these safety issues, positioning the ALA-002 development program to potentially receive favorable regulatory approval.

PharmAla Biotech Holdings Inc. is committed to the research, development, and manufacturing of MDXX class molecules, with a particular focus on MDMA. The company aims to alleviate the global shortage of generic, clinical-grade MDMA for clinical trials and commercial sales in select markets, while also developing novel drugs within the same class. PharmAla is currently the only company providing clinical-grade MDMA for patient treatments outside of clinical trials. Its research and development unit has successfully completed proof-of-concept research for several intellectual property families, including its lead drug candidate, ALA-002. PharmAla operates under a "regulatory first" principle, believing that success in the psychedelics industry depends on maintaining excellent relationships with regulatory bodies.