Opiant Pharmaceuticals has reported negative top-line results from the Phase II clinical trial conducted to study its naloxone product OPNT001 to treat bulimia nervosa, a potentially life-threatening eating disorder.
Formulated as a nasal spray, OPNT001 is an opioid antagonist candidate. It is said to have demonstrated a rapid absorption profile.
The Phase II trial failed to meet the primary endpoint of minimising the number of binging days from baseline to week eight. Key secondary efficacy endpoints of the study were also not met.
However, the therapeutic was observed to be generally safe and well-tolerated, with adverse events being minimal.
Opiant Pharmaceuticals conducted the randomised, double-blind, placebo-controlled trial in up to 80 UK patients to assess OPNT001’s safety, tolerability and effect on clinical outcomes such as changes in eating behaviour.
Based on the data obtained during the trial, the company decided to cease the development of the product for bulimia nervosa and focus on other candidates in its pipeline.
Opiant Pharmaceuticals CEO Roger Crystal said: “The company’s focus for 2019 remains on conducting the pivotal trial for OPNT003, nasal nalmefene for opioid overdose, preparing to enrol patients into a Phase II study for OPNT002, nasal naltrexone, for the treatment of Alcohol Use Disorder and progressing the development of OPNT004, drinabant, for acute cannabinoid overdose.”
Bulimia Nervosa patients suffer from binge eating that is followed by strategies such as purging and fasting to prevent weight gain. The disorder could also lead to psychiatric disorders, including depression, anxiety and substance abuse.
Fluoxetine is currently the only medication approved by the US Food and Drug Administration (FDA) to treat bulimia nervosa.