By Staff Reports
(DGIwire) – Bulimia Nervosa, drug abuse, alcohol abuse: what, if anything, do these conditions have in common? Increasingly, researchers are coming to believe the answer may lie in how the brain’s reward center responds to food, opioids and alcohol. And some believe that learning more about what is going on inside the brains of those who exhibit the symptoms of these disorders could potentially be the key to improved treatment.
“Consider compulsive bingeing, which is one of the major symptoms of Bulimia Nervosa,” says Roger Crystal, M.D., CEO of Opiant Pharmaceuticals. “This behavior has features in common with other addiction disorders, particularly with how the brain’s reward centers are activated. A certain class of drugs, known as opioid antagonists, has already shown success in mitigating opioid overdose and so might offer a successful path for other conditions as well.”
People with Bulimia Nervosa have recurrent and frequent episodes of eating unusually large amounts of food and feeling a lack of control over these episodes, reports the National Institute of Mental Health. This binge eating is followed by behavior that compensates for the overeating, such as forced vomiting, excessive use of laxatives or diuretics, fasting, excessive exercise or a combination of these behaviors.
Opiant has initiated a Phase 2 clinical study evaluating its novel nasally delivered opioid antagonist candidate, OPNT-001, as a potential treatment for Bulimia Nervosa. OPNT-001 is absorbed rapidly, and allows for potentially targeted dosing. With its development, the company is continuing to leverage its expertise in nasally delivered opioid antagonists, which led to its successful development of NARCAN Nasal Spray for opioid overdose, to address broader chronic addiction disorders such as Bulimia Nervosa.
Substance use, addictive and eating disorders are extremely common; more than 22.7 million Americans suffer from a substance use disorder, according to the Substance Abuse and Mental Health Services Administration (SAMHSA), while the National Association of Anorexia Nervosa and Associated Disorders (ANAD) reports that more than 30 million Americans struggle with an eating disorder.
The Phase 2 study will enroll up to 80 patients in the U.K. who have been diagnosed with Bulimia Nervosa. The study is designed to evaluate OPNT-001’s safety and tolerability, as well as its impact on clinical outcomes, such as changes in eating behavior. Opiant expects to report topline data from this study in the first half of 2018.
“Treatments based on the addiction model of bingeing may be of benefit in forging a way forward for those with Bulimia Nervosa,” adds Crystal. “If the binge-eating aspect of this disorder is a form of addictive behavior—and if brain patterns in response to food match those seen in patients with drug and alcohol disorders—this may signal a clear way forward to improved treatment. Data from our study will let us know if we are on the right path.”