Awakn Life Sciences recently announced the completion of its feasibility study for its proprietary formulation of MDMA using Catalent’s Zydis® orally disintegrating tablet (ODT) technology.
The study began in February 2023 and evaluated a variety of chemical parameters and several aspects of MDMA on Catalent’s Zydis ODT technology.
Awakn stated that the study aimed to determine if MDMA is stable on Catalent’s Zydis ODT technology and is suitable for pre-gastric absorption to optimise the delivery of MDMA. Addtionally, to potentially address known pharmacokinetic challenges of MDMA in oral capsules for gastric absorption.
The company has confirmed that it has identified MDMA as stable on Catalent’s Zydis ODT technology and suitable for pre-gastric absorption.
Professor David Nutt, Chief Research Officer of Awakn, stated: “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.”
Anthony Tennyson, Chief Executive Officer of Awakn, added: “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.”
Awakn will now proceed to testing its proprietary formulation of MDMA using Zydis ODT technology against oral capsule MDMA in vivo.
The study was conducted at Catalent’s Swindon, UK facility.
