This article is more than 5 years old. Information may no longer be current.
Phase 2 study of OPNT001 for bulimia completes patient enrollment
Click Here to Manage Email Alerts
Opiant Pharmaceuticals has completed patient enrollment for its phase 2 clinical trial of OPTN001, a naloxone nasal spray for the treatment of bulimia nervosa, according to a press release.
Currently, only the antidepressant fluoxetine is approved for bulimia; however, its efficacy is limited. In this phase 2 randomized, double-blind, placebo-controlled study, researchers will evaluate the safety and tolerability of OPNT001, along with its impact on various clinical outcomes, in 86 patients from clinical sites across the U.K., according to the release. The primary endpoint is to reduce the number of binge-eating days.
Opiant expects to report data from this trial in early 2019.
“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,” Susan L. McElroy, MD, chief research officer at Lindner Center of HOPE, and psychiatry and behavioral neuroscience professor at the University of Cincinnati, said in the release.
“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,” she continued. “It may also support medication adherence because once OPNT001 is administered intranasally, the treatment cannot be purged.”