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MDMA

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MDMA

MDMA/Zydis® Program

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.

MDMA/Zydis Program

Goal:
Develop MDMA into an Oral Disintegrating Tablet (ODT) for pre-gastric absorption to address known pharmacokinetic challenges with MDMA in oral tablet format.

Status:
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.

Near-term Catalysts:

• • Complete feasibility study
• • Execute excusive global licensing agreement with Catalent for MDMA on their Zydis® platform ODT technology
• • Pre-clinical pharmacokinetic study Singlespecies toxicology
• • Submit IND application to FDA
• • Execute global licensing agreement for Phase I data of patent pending proprietary formulation of (S)-ketamine
• • Submit IND application to FDA
  

Zydis Technology

• Zydis® ODT fast-dissolve formulation is a unique, patent protected freeze-dried oral solid dosage form that disperses almost instantly, typically less than 3  seconds in the mouth – no water required
• Enhances pharmacokinetics through pre-gastric absorption, to improve PK and patient compliance
• Faster onset of effects
• Possibility to shorten therapy sessions, reducing cost, improving experience and outcomes

Proposed Timeline and Milestones – Mdma/Zydis

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