News Release Details

Opiant Pharmaceuticals, Inc. Announces FDA Approval of 2mg Formulation of NARCAN (naloxone HCI) Nasal Spray

January 26, 2017 at 11:24 AM EST
2mg Formulation Indicated for Patients At-Risk for Severe Opioid Withdrawal

SANTA MONICA, Calif., Jan. 26, 2017 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (OTCQB:OPNT), a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive and eating disorders, today announced that the U.S. Food and Drug Administration has approved the 2mg formulation of NARCAN® Nasal Spray for opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts. NARCAN® is partnered with and marketed in the U.S. by privately-held Adapt Pharma.  

“The approval of the two-milligram formulation of NARCAN® Nasal Spray provides an important new dosing option for patients at risk of severe opioid withdrawal, and demonstrates our ongoing commitment to support our commercialization partner, Adapt Pharma, with continued innovation in the area of opioid dependence,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “We believe naloxone HCI has broad clinical utility in treating addiction disorders, and we look forward to further evaluating this promising compound in additional indications in the clinical setting.”  

In December 2016, Opiant entered into an agreement with SWK Holdings Corporation (“SWK”) whereby SWK acquired the rights to certain royalties and milestone payments related to NARCAN® Nasal Spray for up to $17.5 million. Opiant received $13.7 million at closing and is eligible to receive an additional $3.75 million contingent on the achievement of certain future net sales milestones.

NARCAN® Nasal Spray 4mg is a concentrated naloxone nasal spray indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN® Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. The 4mg formulation was approved by the FDA in November 2015, and became commercially available in February 2016. NARCAN® Nasal Spray is not a substitute for emergency medical care.

Indications and Important Safety Information:

About Opiant Pharmaceuticals, Inc.

Opiant Pharmaceuticals, Inc., is a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive and eating disorders. Over 45 million people in the U.S. 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 U.S. and Canada by the company’s partner, Adapt Pharma Limited. For more information please visit:

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Corporate Contact:

Susan Forman

Glenn Garmont
Senior Vice President

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