Biotech
Wednesday, October 4th, 2023 3:24 pm EDT
Awakn Life Sciences Corp. has completed a feasibility study for its proprietary formulation of MDMA (3,4-methylenedioxymethamphetamine) 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 pregastric 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 pregastric absorption.
The study was conducted at Catalent’s Swindon, United Kingdom, 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.
About Awakn Life Sciences Corp.
Awakn Life Sciences 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 285 million people globally for which the current standard of care is inadequate. Awakn’s goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and the company’s strategy is focused on commercializing its research and development pipeline across multiple channels.
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