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Top-line Results Expected in First Quarter of 2019
SANTA MONICA, Calif., Nov. 05, 2018 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (NASDAQ: OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions and drug overdose, today announced that the Last Patient, Last Visit (LPLV) occurred on November 2, 2018, in its Phase 2 clinical trial of OPNT001, a naloxone nasal spray, for the treatment of Bulimia Nervosa. Opiant expects to report top-line data from this trial in the first quarter of 2019.
“The rapid absorption profile of OPNT001 has the potential to address the unique needs of patients with Bulimia Nervosa, in particular because it allows on demand dosing, enabling patients to regain control of their disease,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “Opiant remains on track to report top-line results early next year, and we are continuing to explore self-commercialization opportunities.”
The Phase 2 randomized, double-blind, placebo-controlled study is evaluating the safety and tolerability of OPNT001, as well as its impact on various clinical outcomes, including changes in eating behavior. The primary endpoint of the study is a reduction in binge eating days. The study includes a total of 86 patients across 19 clinical sites in the United Kingdom. Patient enrollment was completed on September 4, 2018.
About Bulimia Nervosa
Bulimia Nervosa is a serious and potentially life-threatening eating disorder affecting approximately 1 million Americans annually, and is characterized by binge eating followed by purging, fasting and other strategies to prevent weight gain. Patients are also 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 U.S. Food and Drug Administration (“FDA”) approved medication to treat Bulimia Nervosa. However, the remission rate with fluoxetine, both alone and combined with psychotherapy, ranges from only 19-41 percent.
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.
OPNT001 uses 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 addictions and drug overdose. National Institute on Drug Abuse, a division of the National Institutes of Health, describes addictive 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. Opiant's first drug overdose product, NARCAN® Nasal Spray, is approved for marketing in the U.S. and Canada by its commercialization partner, Adapt Pharmaceuticals, now owned by Emergent BioSolutions, Inc. For more information please visit: www.opiant.com.
This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” or “continue” or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.
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