Narcan maker Opiant shelves bulimia program after mid-stage flop
Narcan maker Opiant Pharmaceuticals has admitted defeat in a mid-stage trial testing a nasal spray version of naloxone in patients with bulimia, prompting the California-based company to abandon the development of the formulation altogether.
The Phase II trial tested the drug — OPNT001 — against a placebo in 86 patients with bulimia. The potentially life-threatening, addictive eating disorder is typically seen in women, and is characterized by a cycle of binging and compensatory behaviors such as self-induced vomiting, fasting, excessive exercise or misusing laxatives to make up for the gluttony. Cognitive behavioral therapy is considered the primary treatment for bulimia, according to the British Medical Journal.
The main goal of the study — to reduce the number of binge-eating days by week 8 — was not met; nor were any secondary endpoints, Opiant disclosed on Thursday, without providing any details.
Estimates from the non-profit National Association of Anorexia Nervosa and Associated Disorders suggest that 1.5% of American women suffer from bulimia in their lifetime.
Roger CyrstalCEO Roger Crystal said the company has elected to shelve the program to focus its resources on its other drugs in development: conducting a pivotal trial for OPNT003, a nasal version of nalmefene for opioid overdose; enrolling patients into a Phase II study for OPNT002, nasal naltrexone, for use in alcohol use disorder; and progressing the development of OPNT004 — which Opiant in-licensed from Sanofi $SNY late last year — for acute cannabinoid overdose.
Amidst the raging abuse, misuse and overdose of opioids in the United States, Opiant’s $OPNT Narcan — a nasal version of naloxone widely used by first responders, police officers and emergency medical technicians for suspected or emergency opioid overdose — is sold by partner Adapt Pharma, a unit of Emergent BioSolutions $EBS. Two doses of the treatment, now available over-the-counter, are approved by the FDA for community use, which in effect means an individual does not have to be medically trained to use it.
