Opiant Pharmaceuticals recently announced the outcomes from a study that test their new delivery system for an opiate-overdose medication. Opiant is well-known in the pharmaceutical world as the company that developed the first FDA-approved nasal spray medication for drug-overdoses called NARCAN. Now the company hopes to add to their portfolio with a new drug that will help reverse overdoses from synthetic opioids such as Fentanyl.
Overdoses are a serious problem in the United States. Recent data from the U.S. Centers for Disease Control show that there were an estimated 100,306 drug overdose deaths from April 2020 – April 2021. Of these deaths, 75,673 were reported to be from opioids such as heroin. And of the 75,673 opioid-related deaths, a reported 64,178 or 84% of these deaths involved synthetic opioids. The National Institute on Drug Abuse reports that deaths from fentanyl and other synthetic opioids have steadily increased over the past 6 years.
Illegally manufactured fentanyl is easier and less costly to make, distribute, and sell when compared to opioids such as heroin. Because of this, fentanyl continues to significantly contribute to overdose deaths. In fact, fentanyl is frequently mixed in with other drugs as a cheap way to make them more potent. This is at the heart of the issue with fentanyl overdoses, as the small quantity of fentanyl required to cause an overdose makes judging the correct dose difficult, and when individuals are unaware that their drugs contain fentanyl, the risk of overdose is even higher. As stated in a report in the British Medical Journal, “most Americans who died from an overdose last year were killed by a drug that they did not know they were taking.”
While there are currently drugs that help reverse opioid overdoses, such as NARCAN, these drugs may not be as effective against the more powerful synthetic opioids. This is where Opiant Pharmaceuticals believes their drug can help. Opiant is using their nasal spray technology to deliver a drug called nalmefene to reverse synthetic-opioid overdoses. Nalmefene has already been approved for use by the FDA for the reversal of opioid drug effects, but is not currently in use. Opiant believes that, because of nalmefene’s long half-life and high-affinity for opiate receptors, the drug will be more effective in combating synthetic opioid overdoses.
The company’s new data showed that nasal spray administration of nalmefene led to a rapid nasal absorption of the drug, a long plasma half-life (approximately 11 hours), and demonstrated that the drug is safe and well-tolerated at multiple doses. Dr. Roger Crystal, CEO of Opiant said, “We are pleased that this study has met our objective of demonstrating safety, tolerability, and pharmacokinetic equivalence across multiple nasal doses. These data are fully consistent with the rapid delivery of high plasma concentration of nalmefene.” The company will continue to test their drug in comparison to other overdose medications, and if positive, the company will apply for full approval with the FDA to move the drug and delivery system to market.
Sources: Opiant Pharmaceuticals; CDC; NIDA; British Medical Journal; DEA; Federal Register; Opiant - Pipeline
