Else Nutrition

Awakn Life Sciences Completes MDMA Zydis(R) ODT Feasibility Study

04 October 2023
  • Study Confirms MDMA Is Stable on Zydis(R) ODT and Suitable for Pre-Gastric Absorption

Toronto, Ontario--(Newsfile Corp. - October 4, 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.

www.AwaknLifeSciences.com | Twitter | LinkedIn

Notice Regarding Forward-Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as "forward-looking statements"). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company's future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "continues", "forecasts", "projects", "predicts", "intends", "anticipates", "targets" or "believes", or variations of, or the negatives of, such words and phrases or state that certain actions, events or results "may", "could", "would", "should", "might" or "will" be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to:COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company's public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company's and Awakn's securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
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Media Enquiries:
Gordo Whittaker, CMO, Awakn Life Sciences
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