Burden of Substance Use and Eating Disorders

“As I have traveled across our extraordinary nation, meeting people struggling with substance use disorders and their families, I have come to appreciate even more deeply something I recognized through my own experience in patient care: that substance use disorders represent one of the most pressing public health crises of our time.”

– Vivek Murthy, MD, MBA (former Surgeon General)

Substance use and eating disorders are chronic relapsing diseases associated with long-lasting changes in the brain.  They affect people of all ages and backgrounds, causing both individual and societal harm.  Individual harms include compromised physical and mental health, loss of productivity at work, and a reduced quality of life such as an increase in problems at home.  Further, high risk behaviors associated with opioid and alcohol misuse have been linked to increased crime, violence, spread of infectious diseases and healthcare costs, presenting an immense societal burden.

The economic costs associated with treating these disorders and their medical and societal consequences are significant.  NIDA reports that abuse of tobacco, alcohol, illicit drugs and prescription opioids costs the United States more than $740 billion annually with respect to healthcare, lost work productivity and crime. NIDA also reports that treatment is cost-effective: for every $1 spent on addiction treatments, up to $12 is saved in criminal and healthcare costs.  Similarly, eating disorders also represent a significant societal burden.  From a 2015 study, it has been estimated that the economic impact of eating disorders is more than $270B annually in personal, workplace and healthcare costs.

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.

Patient Population with Substance Use and Eating Disorders

Economic Impact of Substance Abuse

Eating Disorders

Bulimia Nervosa (BN) is a severe, life-threatening disorder affecting approximately 2.5 million people in the United States (1-2%).  The great majority of patients are women.  BN can be more difficult to detect than other eating disorders because patients are often normal weight, and may not disclose their abnormal eating behaviors.  While BN patients binge eat, the key differentiator between BN and binge eating disorder (BED), another serious eating disorder, is that BN patients exhibit compensatory behaviors such as purging (including self-induced vomiting and abuse of laxatives, diuretics or enemas) after a bingeing episode.  Over time, this cycle can have severe health consequences, including electrolyte imbalances (leading to heart problems), gastric rupture, inflammation and rupture of the esophagus, tooth decay and staining, and peptic ulceration and pancreatitis.

Fluoxetine, an antidepressant, is currently the only FDA-approved drug indicated for the treatment of BN.  Nonetheless, the efficacy of fluoxetine is low: for every 9-10 patients treated, remission is seen in only one patient.

For patients with BN and binge eating disorder (BED), eating highly palatable and calorically dense foods induces a release of naturally occurring opioid-like peptides (this group of peptides are often referred to as endorphins) in the brain.  The pleasurable feeling produced by the release of these endorphins is one of the principal drivers that perpetuate bingeing behavior.  Because binge eaters feel a loss of control and persist despite negative consequences, BN patients and individuals with SUDs (such as alcohol and opiate use disorder) are thought to have a similar imbalance of the brain’s reward circuitry.  Imaging studies have illustrated similar patterns of brain activation during anticipation and receipt of palatable foods observed in individuals with substance use disorders.¹

Because release of endorphins appears to be triggered by highly palatable and calorically dense foods, Opiant is developing OPNT001, a nasal opioid antagonist to treat patients with BN on an as needed basis, with a Phase 2 randomized, placebo-controlled study underway in the United Kingdom.

¹ Finlayson G et al. Implicit wanting and explicit liking are markers for trait binge eating. A susceptible phenotype for overeating. Appetite (2011); Gearhardt AN, Yokum S, Orr PT, Stice E, Corbin WR, Brownell KD. Neural Correlates of Food Addiction. Arch Gen Psychiatry (2011)

Economic Impact of Eating Disorders