Awakn Life Sciences has announced that Awakn Clinics Trondheim is now open and that it has initiated a feasibility study of MDMA leveraging Catalent’s proprietary Zydis ODT fast dissolve technology.
Awakn Clinics Trondheim is the second Awakn clinic operating in Norway with a further two clinics already based in the UK. The clinic is part of the second stage of Awakn’s Nordic expansion plans, following on from last November’s announcement of a move to a larger premises for its Oslo clinic, which is scheduled for Q2 2023.
Awakn’s Nordic expansion is being led by its Regional Director of the Nordics, Dr Lowan Stewart a renowned figure in the Nordic medical community. He was responsible for the adoption of ketamine therapy into the public healthcare system in Norway.
Anthony Tennyson, Awakn’s CEO commented: “We are delighted to open our second clinic in Norway and our fourth clinic overall.
“Our goal as a company is to provide our breakthrough therapeutics to the vast number of people who are in desperate need of a new and more effective treatment option. Our new clinic in Trondheim does exactly this and allows us to provide these treatments to a whole new cohort of people in central Norway.”
MDMA and fast dissolve technology
Zydis ODT is a unique, freeze-dried, oral solid dosage form that disperses almost instantly in the mouth, allowing for dosing with no water required. When formulated appropriately, the technology affords the potential for better pre-gastric absorption, a more efficient delivery, rapid onset of effects, an enhanced patient experience and compliance.
The study is focused on establishing the feasibility of using Catalent’s Zydis ODT technology for the formulation and delivery of MDMA.
Awakn has stated that a variety of chemical parameters are presently being evaluated to access preliminary formulations and, if proven to be feasible, a viable production formulation will be developed.
Awakn’s CSO, Shaun McNulty, commented on the news: “Catalent is a world leader in the field of formulation and their Zydis ODT technology is the gold standard for rapid, safe, and consistent delivery of drugs to patients.
“The Zydis platform offers the potential to minimise both MDMA dose and the duration of therapy sessions. This study has the potential to demonstrate that Zydis ODT technology can provide an ideal MDMA formulation option both for patients and for health care providers.”
The ultimate aims of the study are to optimise the delivery of MDMA to minimise the amount of drug required to deliver efficacy, minimise variability in absorption, and to increase the overall speed of onset.
Due to the faster onset of effects of Zydis ODT technology, there is the possibility to shorten therapy sessions and, through pre-gastric absorption and bypassing of the first-pass metabolism, there is potential to enhance pharmacokinetics.
