By Alex Keown


Shares of Opiant Pharmaceuticals fell in trading Thursday and continue to slide in premarket trading this morning after the company announced its Phase II trial evaluating a naloxone nasal spray for the treatment of bulimia nervosa failed to meet primary endpoints and will discontinue the program.

Santa Monica, Calif.-based Opiant, the maker of the heroin-overdose drug Narcan, said its asset OPNT001 did not reduce the number of binging days from baseline to week eight in the mid-stage study. Key secondary efficacy endpoints were also not met, the company said.

Bulimia nervosa (BN) is a serious and potentially life-threatening eating disorder that primarily affects women. The disorder is characterized by binge eating followed by purging, fasting, and other strategies to prevent weight gain. BN patients are at a heightened risk of other psychiatric disorders including depression, anxiety and substance abuse. Currently, there is only one treatment approved by the U.S. Food and Drug Administration for BN, fluoxetine, which is the anti-depressant Prozac.

Due to the results of the Phase II trial, Opiant Chief Executive Officer Roger Crystal said the company will not continue to allocate additional resources to develop OPNT001 for bulimia nervosa. The funds that were allocated for that project will be invested in other areas of the company’s pipeline, Crystal said Thursday. He expressed his gratitude to the researchers who worked on the project, as well as the patients and their families involved with the study.

In the Phase II trial, OPNT001 was generally safe and well-tolerated with minimal adverse events alongside good patient compliance.

With the closing of the bulimia nervosa study, Crystal pointed to the key projects the company will focus its resources on this year.

“The company’s focus for 2019 remains on conducting the pivotal trial for OPNT003, nasal nalmefene for opioid overdose, preparing to enroll 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,” Crystal said in a statement.

In an interview with BioSpace earlier this year, Crystal pointed to drinabant as a potential solution for a problem that is increasing. Drinabant, which was licensed from Sanofi in December 2018 by Opiant, a cannabinoid CB-1 receptor antagonist that will be used in an emergency setting for acute cannabinoid overdose that typically results from the ingestion of so-called edibles. While not as life-threatening as opioid overdose, Crystal said cannabinoid overdoses are likely to increase, particularly as more states legalize marijuana. In Colorado, where marijuana has been legalized, Crystal said there was a 20 percent increase in ER visits due to cannabinoid overdoses. In 2016 there were about 1 million ER visits related to cannabinoids in the U.S., he said.

Shares of Opiant closed at $14.65 on Thursday.



BioSpace source: