Opiant Pharmaceuticals Announces Publication of Clinical Pharmacokinetic Data Supporting Potential of OPNT003, Nasal Nalmefene, for Treatment of Synthetic Opioid Overdose

SANTA MONICA, Calif., April 08, 2019 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. OPNT, a specialty pharmaceutical company developing medicines for addictions and drug overdose, today announced that clinical pharmacokinetic (PK) data for OPNT003, nasal nalmefene containing Intravail® (dodecyl maltoside), were published online in the Journal of Pharmacology and Experimental Therapeutics and presented on Sunday, April 7, 2019, at the American Society for Pharmacology and Experimental Therapeutics 2019 Annual Meeting. The data in this manuscript, titled "Fighting Fire with Fire: Development of Intranasal Nalmefene for Treatment of Synthetic Opioid Overdose," show that adding the absorption enhancer Intravail® to intranasal nalmefene results in very rapid and robust increases in nalmefene plasma levels with a speed of absorption comparable to intramuscular injection.

"This pilot PK study demonstrates that, in the presence of Intravail®, the absorption of nasal nalmefene is rapid enough to be administered in an overdose rescue situation, when the first minutes are critical," said Phil Skolnick, Ph.D., D.Sc. (hon.), Chief Scientific Officer of Opiant. "These data, together with the very high potency and long half-life of nalmefene, validate the potential of OPNT003 as a rescue medication especially well-suited to treat an overdose of a synthetic opioid such as fentanyl."

The National Institutes of Health's (NIH) leadership recently called for longer-lasting and stronger opioid overdose reversal agents in response to the dramatic rise in overdose deaths linked to synthetic opioids, such as fentanyl. In 2017, synthetic opioid deaths far surpassed fatalities due to either heroin or prescription opioids. 

"The opioid epidemic is now a crisis of high-potency synthetic opioids, in particular fentanyl, and we must fight fire with fire to save lives," said Roger Crystal, M.D., Chief Executive Officer of Opiant. "It is well established in the scientific literature that nalmefene is five times more potent than naloxone at m opioid receptors. The high potency, long half-life and fast absorption of OPNT003 observed in this study are particularly encouraging. We remain on track to launch a pivotal PK trial for OPNT003 this year while advancing our other pipeline candidates for opioid use disorder, alcohol use disorder and acute cannabinoid overdose."

About Synthetic Opioids
Synthetic opioids, such as fentanyl, are responsible for more overdose deaths than either heroin or prescription opioids, with over 28,000 fatalities linked to synthetic opioids in 2017. Synthetic opioids are more potent than heroin (e.g., fentanyl is 50 times more potent than heroin), and especially dangerous because of a rapid onset of action and long half-life. These properties of fentanyl and related synthetic opioids may require continuous monitoring of overdose victims and repeated dosing with short-acting reversal agents like naloxone to initially resuscitate a patient and prevent relapse. A long-acting opioid overdose reversal drug may reduce this burden.

About OPNT003
OPNT003, nasal nalmefene, is in development as a potent, rapid-onset, long-acting opioid antagonist for the treatment of opioid overdose. OPNT003 is designed as a rescue medication that could be especially useful in treating overdose by high-potency synthetic opioids, such as fentanyl. OPNT003 is also being considered as an antidote in a civilian mass casualty event. The development of OPNT003 is supported by grants from the NIH and the Biological Advance Research and Development Agency (BARDA). Opiant intends to pursue a 505(b)(2) regulatory pathway for OPNT003.

About Intravail®
Intravail® is a registered trademark of Neurelis, Inc. Intravail® drug delivery technology enables the non-invasive delivery of a broad range of protein, peptide and non-peptide drugs (up to 30,000 daltons in size) that can currently only be administered by injection. Intravail can be utilized via the oral, buccal, dermal and intranasal routes of drug administration.

About Opiant Pharmaceuticals, Inc. 
Opiant Pharmaceuticals, Inc. is a specialty pharmaceutical company developing medicines for addictions and drug overdose. The National Institute on Drug Abuse, a division of NIH, describes addictive disorders as chronic relapsing brain diseases that burden society at both the individual and community levels. Opiant's first drug overdose product, NARCAN® Nasal Spray, is licensed to Adapt Pharmaceuticals, now owned by Emergent BioSolutions, Inc. For more information, visit www.opiant.com.

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