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Opiant Pharmaceuticals Announces Final Patient Enrolled in Phase 2 Clinical Trial Evaluating OPTN001 in Bulimia Nervosa

(September 04, 2018)

Top-line Results Expected in First Quarter of 2019

SANTA MONICA, Calif., Sept. 04, 2018 (GLOBE NEWSWIRE) --  Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions and drug overdose, today announced that it has completed patient enrollment in its Phase 2 clinical trial of OPTN001, a naloxone nasal spray, for the treatment of Bulimia Nervosa. The Company expects to report top-line data from this trial in the 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 Susan McElroy, M.D., an eating disorders expert at the Lindner Center of HOPE.  “This can help to establish a sense of control, which patients with Bulimia desperately want, and if bingeing is controlled, patients won’t carry out compensatory behaviors, primarily purging.  It may also support medication adherence because once OPNT001 is administered intranasally, the treatment cannot be purged.”

“The completion of patient enrollment in this study represents an important milestone for our OPNT001 clinical development program and our company,” said Roger Crystal, M.D., Chief Executive Officer of Opiant Pharmaceuticals. “We look forward to top-line results from this study in the first quarter of 2019. With an addressable market of over $1 billion and very few competitive products in development, Bulimia Nervosa may be an attractive indication for self-commercialization.”

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 United Kingdom.

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