The U.S. Food and Drug Administration (FDA) approved Wednesday the first nasal spray treatment for emergency-case opioid overdose.
Developed by Ireland-based Adapt Pharma Ltd, the Narcan (naloxone) nasal spray is an antidote used for opioid overdose for almost 45 years but previously approved only in injectable forms.
According to data from the U.S. Centers for Disease Control and Prevention, opioid overdose results in around 23,500 deaths in the country in 2013, a four-fold increase from 1999. These deaths primarily occurred in non-medical situations, emphasizing the need for administering effective emergency intervention.
To be launched in January, Narcan is also expected to be widely covered by health insurance with affordable co-pays, said Seamus Mulligan, chief executive of Adapt Pharma.
Fighting opioid abuse is top FDA priority, said acting agency commissioner Dr. Stephen Ostroff.
"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," he explained.
The nasal spray requires no assembly to be used immediately and is said to deliver a consistent, measured dose. Clinical trials showed that administering it in one nostril provided about the same or higher levels of naloxone as a single dose of the approved intramuscular injection.
Using it in opioid-dependent individuals may result in severe withdrawal symptoms, including body ache, diarrhea, fever, and increased heart rate.
The increased access to and use of naloxone is part of the Health and Human Services secretary Sylvia Burwell's strategy back in March this year to address the opioid epidemic.
For National Institute on Drug Abuse director Dr. Nora Volkow, prevention remains the ultimate goal but the "national crisis" can be better solved through these efforts borne out of public-private partnerships. "This easy-to-use intranasal formulation will no doubt save many lives," she said.
The nasal spray is priced for group purchases, including for law enforcement and local school districts, at a discounted rate of $37.50 per 4 milligrams. Existing injectable forms of the drug are currently available at $75 to $100.
According to Wall Street analysts, naloxone in nasal spray form could garner annual earnings of $25 million in the United States alone, with competitors that include older injections and a pen-like injector tool usually fetching for a few hundred dollars.