Awakn Life Sciences has acquired exclusive rights to the data from the first published trial exploring MDMA as a treatment for addiction.
The Bristol Imperial MDMA in Alcoholism Study (BIMA) investigated the role of MDMA-assisted psychotherapy in treating alcohol use disorder (AUD).
The results from the study indicated that MDMA has the potential to be more effective than conventional treatments.
Data from the Open-label safety, tolerability and proof-of-concept study study will help Awakn design and execute an efficient clinical programme of its own.
Awakn can now move into a phase IIb randomised controlled trial (RCT) in the UK.
If its research is successful, Awakn hopes to secure marketing authorisation to treat AUD in the UK and EU.
Dr. Ben Sessa, Chief Medical Officer of Awakn, said:
“Drinking behavior outcomes from the BIMA phase IIa study that Awakn just acquired indicates that MDMA has the potential to be more effective at treating AUD, with only a 20% relapse rate within the first nine months.
“This compares very favourably with the current best available traditional treatments for patients’ post-detox with AUD.
“This data acquisition is an important step along Awakn’s path to providing lifesaving MDMA treatment to the millions of people currently suffering with AUD, offering better outcomes without the exorbitant rates of relapse.”
In 2017, the FDA in the US declared MDMA-assisted psychotherapy a ‘Breakthrough Therapy’ for post-traumatic stress disorder (PTSD).
This status is designed to help speed up the development of a drug that has shown clinical potential for treating a serious condition substantially better than currently-available treatments.