The FDA has fast-tracked approval of a simple-to-use nasal spray to treat opioid overdose, called Narcan. Narcan can be a life-saving medication that stops or reverses the effects of an opioid overdose from classes of medicines including oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin.
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.
“While naloxone will not solve the underlying problems, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose,” said Stephen Ostroff, M.D., acting commissioner, Food and Drug Administration.
Nalaxone has been approved in injectable form, but many first responders and caregivers see real advantages to the nasal spray, including that it’s easier to use and removes the risks of blood contamination with needles.
Narcan is available only by prescription, and is easily administered by anyone, even those without medical training. The drug is sprayed into one nostril while the patient is lying on his or her back, and can be repeated if necessary.
The FDA granted fast-track designation and priority review for Narcan nasal spray, which means it went through a process designed to facilitate development and expedite review of the drug because it addresses an unmet medical need that is serious.
“We heard the public call for this new route of administration, and we are happy to have been able to move so quickly on a product we are confident will deliver consistently adequate levels of the medication – a critical attribute for this emergency life-saving drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
Increasing access to naloxone is part of the targeted strategy that Health and Human Services Secretary Sylvia M. Burwell put forward in March to address opioid overdoses and save lives.