Substance Use Disorders
Based on NIDA estimates, over 47 million Americans used an illicit drug in the past year, of which 12.5 million reported misusing prescription pain relievers and over 800 thousand reported using heroin. This study also revealed that 67 million Americans reported binge drinking and 17 million reported heavy drinking during the past month.
For many of these individuals, prolonged and repeated misuse of any of these substances can produce changes to the brain that can lead to a substance use disorder; severe and chronic substance use disorders are commonly referred to as addictions. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), 17 million individuals suffer from an Alcohol Use Disorder (AUD) and 2.5 million suffer from an Opioid Use Disorder (OUD). Abuse of these substances can lead to impaired judgment, violence, and high-risk behaviors. Examples of high-risk behaviors include driving under the influence, unsafe sexual practices, and needle sharing, which may in turn increase the risk of injury, death, and infectious disease.
To address the growing opioid epidemic, Opiant collaborated with NIDA to introduce NARCAN® Nasal Spray 4mg dose in the United States and Canada through our commercial partner, Adapt Pharma. Following its approval in 2015, the FDA approved a 2mg dose in 2017. We have also in-licensed a novel, heroin vaccine developed by the Walter Reed Army Institute of Research (WRAIR) in collaboration with NIDA.
Alcohol Use Disorder
Problem drinking that becomes severe is given the medical diagnosis of “Alcohol Use Disorder” (AUD). According to the National Institute on Alcohol Abuse and Alcoholism and SAMHSA, approximately 7.2 percent of adults in the United States (17 million individuals) met the diagnostic criteria for AUD in 2012.
Like other abused substances, alcohol exerts powerful effects on the brain circuitry which impact mood and cognition, reduce motor coordination, and lead to risky or violent behaviors. Over time, high levels of alcohol consumption have been linked to multiple long term health consequences, damaging multiple organs including the heart, liver and pancreas. Long term alcohol consumption is also associated with the development of certain types of cancers (e.g., esophageal and pancreatic cancer) and an impaired immune system.
There are three medications currently approved to treat AUD in the United States: disulfiram, acamprosate and naltrexone (daily oral or monthly injection). These medications have significant limitations, including low efficacy and poor adherence.
Traditionally, abstinence has long been viewed as the only acceptable outcome for individuals with AUD. However, more recent findings have shown that reducing the quantity of alcohol consumed results in beneficial health outcomes as well as improved psychosocial functioning compared to continued heavy drinking.
Using its intranasal delivery technology, Opiant is developing nasal naltrexone OPNT002, an opioid antagonist to treat AUD, giving the patient more control over dosing while rapidly delivering high concentrations of medication to the brain whenever the patient has the urge to drink.