The U.S. Food and Drug Administration has approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, which can stop or reverse the effects of an opioid overdose.
The rapid approval of the nasal spray form is seen as a boon for first responders in battling what has been called an “epidemic” of opioid abuse, overdoses and deaths. Opioids include prescription pain medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin — which many people addicted to painkillers switch to because of its relatively low cost.
“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, M.D., acting commissioner, Food and Drug Administration. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”
Until this approval, naloxone was only approved in injectable forms, most commonly delivered by syringe or auto-injector. Many first responders and primary caregivers, however, feel a nasal spray formulation of naloxone is easier to deliver, and eliminates the risk of a contaminated needle stick.
Drug overdose deaths, driven largely by prescription drug overdoses, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade.
When someone overdoses on an opioid, it can be difficult to awaken the person, and breathing may become shallow or stop leading to death if there is no medical intervention. If naloxone is administered quickly, it can counter the overdose effects, usually within two minutes.
The FDA granted fast-track designation and priority review for Narcan nasal spray. Fast track is a process designed to facilitate development and expedite review of drugs intended to treat serious conditions and that demonstrate the potential to address an unmet medical need.
The National Institute on Drug Abuse played a critical role in the development of Narcan nasal spray as well, helping to design and carry out clinical trials to determine that the spray worked as quickly and effectively as an injection. NIDA then worked with its private sector partners to obtain FDA approval.
“This easy-to-use intranasal formulation will no doubt save many lives,” said Nora Volkow, M.D., director, National Institute on Drug Abuse at the National Institutes of Health. “While prevention is the ultimate goal, the drug’s successful development illustrates how public/private scientific partnerships can play an important role in responding to a national crisis right now.”