Opiant Pharmaceuticals, Inc. Announces Initiation of Phase 2 Clinical Trial Evaluating OPNT001 in Bulimia Nervosa

SANTA MONICA, CA, USA I March 20, 2017 I Opiant Pharmaceuticals, Inc. (“Opiant”) (OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions, today announced that the Company has initiated a Phase 2 clinical trial evaluating its novel nasally-delivered opioid antagonist candidate, OPNT001, as a potential treatment for Bulimia Nervosa.

“Bulimia Nervosa is a serious and potentially life-threatening eating disorder for which new treatment options are desperately needed,” said Janet Treasure OBE, PhD, FRCP, FRCPsych, Professor of Psychiatry at King’s College London, and principal investigator of the study. “Compulsive bingeing has features in common with other addiction disorders, providing strong rationalization for the use of opioid antagonists to mitigate the frequency of these harmful behaviors. OPNT001 is absorbed rapidly, and allows for potential targeted dosing, which we believe could address the unique needs of patients suffering from this serious disorder.”    

“We continue to leverage our expertise in nasally-delivered opioid antagonists, which led to the successful development of NARCAN® Nasal Spray for opioid overdose, to address broader chronic addiction disorders with large and undertreated patient populations,” said Roger Crystal, M.D., Chief Executive Officer of Opiant Pharmaceuticals. “The advancement of OPNT001 into Phase 2 development for Bulimia Nervosa was a key 2017 clinical goal for our Company as we continue to expand and advance our pipeline of promising addiction treatments. We look forward to data from this important study next year.”

This Phase 2 randomized, double-blind, placebo-controlled study will enroll up to 80 patients in the U.K. who have been diagnosed with Bulimia Nervosa. The study is designed to evaluate OPNT001’s safety and tolerability, as well as its impact on clinical outcomes, including changes in eating behavior. The Company expects to report topline data from this study in the first half of 2018.

About Bulimia Nervosa

Bulimia Nervosa is a serious and potentially life-threatening eating disorder affecting mainly females, and is characterized by binge eating followed by purging, fasting, and other strategies to prevent weight gain.  It has a lifetime prevalence of 1-2%, and patients are at a heightened risk of other mental disorders including depression, anxiety and problems with drug and alcohol. The mainstay of treatment is psychotherapy using cognitive behavioral therapy, but this is associated with only moderate treatment success and high relapse rates.  Fluoxetine is currently the only FDA approved medication to treat Bulimia Nervosa. However, the remission rate with fluoxetine, both alone and combined with psychotherapy, ranges from only 19-41%.

The wide variety of individual response to treatment, combined with moderate success of even the most effective treatment approaches, highlights a strong need to develop new and more effective treatments. Research suggests that treatments based on the addiction model of bingeing may be of benefit.  Thus, many experts view binge eating as a form of addictive behavior to foods high in sugar, salt and fat. Furthermore, individuals with “food addiction” exhibit similar patterns of brain activation in response to both the anticipation and receipt of food. This pattern is similar to that observed in patients with drug and alcohol addiction/use disorders.

About OPNT-001

OPNT-001 is Opiant’s proprietary nasal naloxone technology.  The product is covered by three FDA Orange Book-listed patents. PET imaging and promising pharmacokinetic data, which demonstrate rapid absorption, render it uniquely suitable for targeted dosing.

About Opiant Pharmaceuticals, Inc.

Opiant Pharmaceuticals, Inc., is a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive and eating disorders. Over 45 million people in the U.S. have one of these disorders. The National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health (NIH), describes these disorders as chronic relapsing brain diseases which burden society at both the individual and community levels. With its innovative opioid antagonist nasal delivery technology, Opiant is positioned to become a leader in these treatment markets. Its first product, NARCAN® Nasal Spray, is approved for marketing in the U.S. and Canada by the company’s partner, Adapt Pharma Limited. For more information please visit: www.opiant.com.

SOURCE: Opiant Pharmaceuticals

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