MDMA, an investigational medicinal product (IMP), is an entactogen that acts as a releaser and reuptake inhibitor of serotonin, norepinephrine (NE), and dopamine.
MDMA has demonstrated potential efficacy in clinical trials to treat AUD and Post Traumatic Stress Disorder (PTSD), conditions that have trauma as a significant causative factor.
MDMA could also potentially be effective in treating other addictions and mental health conditions which also have trauma as a causative factor.
While MDMA shows excellent promise in trials there are issues that challenge the successful development of MDMA as a marketed drug:
Excessive Treatment Duration: Treatment sessions last between 6 to 8 hours.
Variable Pharmacokinetics: Gastrointestinal absorption and first-pass metabolism negatively effects bioavailability.
Develop MDMA into an Oral Disintegrating Tablet (ODT) for pre-gastric absorption to address known pharmacokinetic challenges with MDMA in oral tablet format.
Awakn has executed an exclusive development agreement with Catalent, a global leader in drug formulation. Agreement focuses on developing and testing a market-ready proprietary formulation and optimized delivery route for MDMA using Catalent’s proprietary Zydis® platform orally disintegrating tablet (ODT) technology.
Proposed Timeline and Milestones – Mdma/Zydis
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