PharmAla Biotech and Cortexa Supply GMP Psilocybin for Therapeutic Use in Australia

LOS ANGELES- PharmAla Biotech Holdings Inc., in collaboration with Cortexa Pty. Ltd., has achieved supplying Good Manufacturing Practice (GMP) Psilocybin for therapeutic use to a patient under the Australian authorized prescriber scheme, marking what the company believes to be a global first. This groundbreaking development allows for the treatment of patients with treatment-resistant depression outside of clinical trials.

The partnership between PharmAla and Australian-based digital health company Vitura Health Ltd. led to the creation of Cortexa, a joint venture established in May 2023. Cortexa has rapidly positioned itself as the sole provider in Australia capable of immediately supplying both GMP MDMA and Psilocybin for clinical trials and prescriptions through the Therapeutic Goods Administration’s (TGA) Authorised Prescriber Scheme. This capability follows the TGA’s decision on July 1, 2023, to reclassify these medicines from Schedule 9 to Schedule 8, enabling authorized psychiatrists to prescribe MDMA for post-traumatic stress disorder and Psilocybin for treatment-resistant depression.

Since the rescheduling, Cortexa has been actively expanding its presence in the Australian psychedelic market, establishing a comprehensive national network that includes research institutes, key opinion leaders, and emerging clinicians. The company has also played a critical role in supporting psychiatrists to obtain authorized prescriber status and has secured supply arrangements for both clinical and prescriptive use into 2024 and beyond.

PharmAla Biotech Holdings Inc., a pioneer in the research, development, and manufacturing of MDXX class molecules, including MDMA, is dedicated to alleviating the global backlog of clinical-grade MDMA to enable both clinical trials and commercial sales in select jurisdictions. As the only company currently providing clinical-grade MDMA for patient treatments outside clinical trials, PharmAla is committed to developing novel drugs within the same class, adhering to a “regulatory first” principle to ensure success through strong regulatory relationships.

This advancement underscores the ongoing efforts to integrate psychedelic medicines into mainstream therapeutic applications, providing new hope for patients with treatment-resistant conditions and further establishing Australia as a leader in the regulated use of psychedelic substances for medical purposes.