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

Opiant Pharmaceuticals, Inc. Announces FDA Approval of 2mg Formulation of NARCAN (naloxone HCI) Nasal Spray
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: http://www.NarcanNasalSpray.com.

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: www.opiant.com.

Forward-Looking Statements

This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” or “continue” or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.

CONTACT INFORMATION:

Corporate Contact:
Investor.relations@opiant.com

Media:
Susan Forman
DGI
sforman@dgicomm.com
212-825-3210

Investors:
Glenn Garmont
Senior Vice President
Argot Partnersglenn@argotpartners.com
212-600-1902

Primary Logo

Opiant Pharmaceuticals, Inc.