Opiant Pharmaceuticals' Partner Submits New Drug Submission


Opiant Pharmaceuticals, Inc. recently announced that its commercial partner for naloxone nasal spray for the emergency reversal of opioid overdose, Adapt Pharma Limited, has submitted a new drug submission (NDS) for the product to Health Canada.

“The need for better access to treatments for opioid overdose is a global challenge and why we developed naloxone nasal spray,” said Roger Crystal, MD, Chief Executive Officer of Opiant. “The product, branded as NARCAN Nasal Spray in the US, was launched in the US in February by our commercial partner, Adapt. We commend Adapt’s efforts to bring this nasally delivered formulation to Canada.”

Currently, the injectable formulation of naloxone is available in Canada, and naloxone has been the standard treatment for opioid overdose in that country for over 40 years. Recently, Health Canada revised the listing of naloxone on the Canadian Prescription Drug list to allow non-prescription use of naloxone for emergency opioid overdose use outside of hospital settings. Adapt anticipates that if naloxone nasal spray is approved in Canada, it will be available without a prescription.

In December 2014, Opiant announced a licensing deal with a subsidiary of Adapt. In exchange for licensing its opioid overdose reversal treatment, Opiant could receive total potential milestone payments of more than $55 million, plus up to double-digit percentage royalties on net sales. Indications and Important Safety Information: http://www.NarcanNasalSpray.com.

Opiant Pharmaceuticals, Inc., is a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive and eating disorders. Over 45 million people in the US have one of these disorders. The National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health (NIH), describes these disorders as chronic relapsing brain diseases, which burden society at both the individual and community levels. With its innovative opioid antagonist nasal delivery technology, Opiant is positioned to become a leader in these treatment markets. Its first product, NARCAN Nasal Spray, is approved for marketing in the US by the company’s partner, Adapt Pharma Limited. Currently, Opiant is developing opioid antagonists for the treatment of substance use, addictive and eating disorders, with a near-term focus on cocaine use disorder and binge eating disorder (BED). For more information, visit www.opiant.com.