Opiant Pharmaceuticals Announces Last Patient, Last Visit in Phase 2 Clinical Trial Evaluating OPNT001 in Bulimia Nervosa
Top-line Results Expected in 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
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
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
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.
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Source: Opiant Pharmaceuticals, Inc.