Managing Director of Emyria Ltd (ASX:EMD) Dr. Michael Winslo speaks to Thomas Warner from Proactive after the clinical-stage biotech company announced it has been granted Authorised Prescriber approval from the Therapeutic Goods Administration (TGA) for MDMA-assisted therapy in post-traumatic stress disorder (PTSD) care.
Winslo explains that Authorized Prescriber Status allows Emyria to prescribe MDMA for post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression, following the TGA's groundbreaking decision to reschedule these substances. Achieving this status demonstrates Emyria's compliance with TGA's stringent requirements, including specialist qualifications, appropriate training, and clinical governance.
Currently, Emyria is conducting clinical trials using MDMA-assisted therapy, laying the groundwork for broader treatment options. With a significant number of Australians suffering from PTSD, many of whom are treatment-resistant, Winslow believes there is a pressing need for more effective treatments.
Emyria aims to replicate the promising results of international clinical trials, offering new treatment options under strict TGA guidelines. He makes it clear that Emyria's current priority is delivering these advanced treatments effectively and sensibly, using the generated revenue and data to support further drug development and innovation.