Opiant Pharmaceuticals Announces Final Patient Enrolled in Phase 2 Clinical Trial Evaluating OPTN001 in Bulimia Nervosa
Top-line Results Expected in First Quarter of 2019
Bulimia Nervosa is a serious eating disorder characterized by binging and purging that impacts about one million Americans. Treatment of Bulimia Nervosa can be challenging, with as many as 30 percent of patients relapsing. Fluoxetine, an orally administered antidepressant, is the only drug currently approved for this indication; however, it has shown limited efficacy.
“OPNT001 has the potential to address the unique needs of this patient population because it has demonstrated a rapid absorption profile and allows for on-demand dosing by patients when they experience the urge to binge,” said
“The completion of patient enrollment in this study represents an important milestone for our OPNT001 clinical development program and our company,” said
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 has enrolled 86 patients across 19 clinical sites in the
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. 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
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 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.
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Source: Opiant Pharmaceuticals, Inc.