Opiant Pharmaceuticals Announces First Patient Dosed in Confirmatory Pharmacokinetic Study Assessing OPNT003, Nasal Nalmefene, for the Treatment of Opioid Overdose
SANTA MONICA, Calif., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today announced the dosing of the first patient in a confirmatory pharmacokinetic
(“PK”) study for OPNT003, nasal nalmefene, for the treatment of opioid overdose. Results from the study are anticipated June 2021.
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 Roger Crystal, M.D., CEO and President, Opiant. “In our initial pilot PK study, OPNT003 demonstrated its potential to work quickly, while offering a longer duration of action compared to currently available opioid overdose rescue medicines. The availability of another therapeutic option that has the potential to act more quickly and last longer could provide a valuable tool in the fight against opioid overdose at a time when deaths continue to increase to historic proportions."
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 National Institute on Drug Abuse (“NIDA”), part of the NIH, and the Biological Advance Research and Development Agency (“BARDA”).
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 May 2020. 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.