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March 12, 2019

Go Medical announces the initiation of the first US clinical study to evaluate the O’Neil Long Acting Naltrexone Implant (OLANI) for the treatment of opioid use disorder (OUD).

Go Medical Industries Pty Ltd, an Australian company, is pleased to announce that as of August 10, 2018, the application for an Investigational New Drug Application (IND) submitted under section 505(i) of the Federal Food, Drug and Cosmetic Act for Naltrexone Subcutaneous Implant was granted.  This allows Go Medical to progress with a development program in the United States towards fulfilling the regulatory requirements for a New Drug Application (NDA) via the 505 b(2) pathway for the OLANI as agreed with the FDA.

Go Medical in collaboration with Dr. Adam Bisaga and Dr. Edward V. Nunes, physicians at Columbia University Department of Psychiatry, initiated the evaluation of the safety and pharmacokinetics of the OLANI.  The National Institute on Drug Abuse (NIDA) has awarded Columbia University approximately USD$6 million (AUD$8.48M) over two years to conduct the initial studies under award UG3DA047720.  Depending on the satisfactory progress of the initial studies, a second UH3 phase of medication development may be awarded with additional USD$13.9 million (AUD$19.65M) of grant funding over three years.

The USA has recently declared a public health emergency related to a dramatic increase in overdoses related to opioids.  As a part of the strategy to combat the epidemic, NIH is funding research to develop new medications to treat OUD.  The OLANI is a new formulation of naltrexone that is a biodegradable implant inserted under the skin on the abdomen via a surgical procedure after the completion of opioid withdrawal (detoxification).  OLANI gradually dissolves releasing Naltrexone over 6 months after the insertion. Naltrexone works as an antagonist (blocker) of opioid receptors.  This reduces or eliminates opioid effects and reduces craving for opioids thereby preventing relapse to opioid use and related harms. Current shorter acting formulations of naltrexone have been approved for the treatment of opioid and alcohol dependence.  The OLANI aims to provide 6 months therapeutic benefit from one administration, although multiple treatments may be required to sustain long-term benefits.



When the clinical trials are completed, Go Medical will submit an NDA. Once the NDA is granted, Go Medical will aim to market the OLANI in the USA which will help to combat the epidemic of deaths related to opioid overdoses.


Issued by Patsy Graieg, CEO, Go Medical