Evaluating the Safety of an Opioid Abuse Treatment

The United States is in the midst of an opioid crisis. Every day, more than 130 people die from overdosing on opioids. An estimated 2.1 million Americans have an opioid-use disorder. Systematic public health and medical interventions are needed to address these complex issues. 

In 2017, in response to this crisis, the U.S. Secretary of Health and Human Services declared a public health emergency.
 
The medication naltrexone can be very effective at helping individuals manage opioid and alcohol dependence by blocking the effects of opioids and reducing cravings. Unfortunately, the most common method for taking the medication is a daily pill, which frequently leads to compliance issues.
 
Australian pharmaceutical company Go Medical Industries Pty Ltd developed the O'Neil Long Acting Naltrexone Implant (OLANI) as an alternative to oral medication. After being implanted under the skin in the abdominal region, the implant slowly releases naltrexone over the course of six months, providing continuous treatment without worrying about daily medication compliance. The biodegradable implant completely dissolves on its own in the body, and a repeat treatment provided by a physician every six months or when clinically indicated. 
 
The first-generation OLANI has been in use in Australia since 2000. Go Medical has reformulated the implants with a higher percentage of naltrexone, but this second-generation OLANI implant is not yet approved for use in the United States.

In the United States, naltrexone is currently available in two types of formulations: once daily oral and once monthly intramuscular injections. 

“Because of frequent treatment with these formulations, poor patient compliance is a major issue. However, the OLANI (once approved by the U.S. FDA) will help patients abstain from opioid use for longer duration without worrying about missing a dose,” said Vijay Kale, Battelle Principal Research Scientist.           
 
Partnering with Go Medical on their development program, Battelle played a key role in designing the safety study to comply with the U.S. Food & Drug Administration’s requirement to support the clinical testing needed for the OLANI to receive U.S. regulatory approval.

Go Medical has recently agreed on a contract with Battelle to conduct a study to further evaluate the toxicity of OLANI. Our research team for this study includes a variety of experts in FDA study requirements, toxicology, veterinary medicine and pathology. 

“This study will be conducted for 18 months under strict adherence to the U.S. government regulations to assess safety of these implants. The results of this safety study will provide detailed information, which will help the U.S. FDA to predict the safety of these implants in patients,” said Vijay.