News Release Details
Opiant Pharmaceuticals Announces First Patient Dosed in Confirmatory Pharmacokinetic Study Assessing OPNT003, Nasal Nalmefene, for the Treatment of Opioid Overdose
Deaths resulting from opioid overdose are at record levels, driven in large part by high-potency synthetic opioids, such as fentanyl. In 2017, the National Institutes of Health’s (“NIH”) leadership called for longer lasting and stronger opioid overdose reversal agents in response to this escalating public health crisis¹.
“OPNT003 represents a potentially promising new approach for treating opioid overdoses,” said
The open label, randomized, crossover study will enroll 68 healthy volunteers and determine the pharmacokinetic profile of intranasally administered nalmefene compared to intramuscularly administered nalmefene. Opiant also intends to conduct a separate pharmacodynamic study in healthy volunteers later this year. The development of OPNT003 is supported by grants from the
The Company plans to file a 505(b)(2) New Drug Application for OPNT003 with the U.S. Food and Drug Administration by the end of 2021.
About Synthetic Opioids
Synthetic opioids, such as fentanyl, are responsible for more overdose deaths than either heroin or prescription opioids, with over 47,000 fatalities linked to synthetic opioids during the 12 months ending
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
About Opiant Pharmaceuticals, Inc.
For more information visit: www.opiant.com.
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- Volkow, N., Collins, F. The Role of Science in Addressing the Opioid Crisis. N Engl J Med. 2017. 377:391-394
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Source: Opiant Pharmaceuticals, Inc.