Study Confirms MDMA Is Stable on Zydis® ODT and Suitable for Pre-Gastric Absorption
TORONTO, CANADA, October 04, 2023 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”), a clinical stage biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), today announces it has completed a feasibility study for its proprietary formulation of MDMA using Catalent's Zydis® orally disintegrating tablet (ODT) technology.
The study, which was initiated in February 2023, evaluated a variety of chemical parameters and several aspects of MDMA on Catalent’s Zydis ODT technology. The aims of the feasibility study were to ascertain if MDMA is stable on Catalent's Zydis ODT technology and is suitable for pre-gastric absorption in order to optimize the delivery of MDMA and potentially address known pharmacokinetic challenges of MDMA in oral capsules for gastric absorption.
Awakn has completed the feasibility study and has identified that MDMA is stable on Catalent's Zydis ODT technology and is suitable for pre-gastric absorption.
The study was conducted at Catalent's Swindon, UK facility, where the company has extensive experience and expertise in developing and manufacturing ODT products using its patented Zydis technology.
Awakn will now proceed to testing its proprietary formulation of MDMA using Zydis ODT technology against oral capsule MDMA in vivo. Anthony Tennyson, Chief Executive Officer of Awakn, said “we look forward to the results, and my hope is the testing will demonstrate that MDMA on Catalent’s Zydis® ODT technology will improve the performance of MDMA and provide significant benefits to patients in the clinic compared to MDMA in oral capsules.”
"We are very pleased with how the feasibility study has progressed and has given us positive data around the stability and suitability of Catalent's Zydis technology for our novel MDMA formulation. This is an important part of our product development strategy, which aims to optimize the delivery of MDMA." said Prof David Nutt, Chief Research Officer of Awakn.
Zydis® is a registered trademark of R.P. Scherer Technologies, Inc., a wholly owned subsidiary of Catalent, Inc.
About Awakn Life Sciences
Awakn Life Sciences Corp. is a clinical stage biotechnology company developing therapeutics to treat addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 285m people globally for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels.
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Anthony Tennyson, CEO, Awakn Life Sciences
Gordo Whittaker, CMO, Awakn Life Sciences