The drug, which does not require assembly or preparation, can counteract an overdose within a few minutes of being administered. Photo by Adapt Pharma
SILVER SPRING, Md., Nov. 19 (UPI) -- There has been a large increase in opioid addiction and death from overdoses during the last 15 years, causing a need for easier, faster ways to treat an overdose.
The Food and Drug Administration fast-tracked the approval of a nasal spray version of the drug naloxone hydrochloride, called Narcan, because it is expected to be easier for anybody, doctors or not, to administer than its previous injectable form. Narcan is expected to be available within weeks.
In addition to the heroin epidemic that's caused overdose death to double since 2001, addiction to and overdose from opioid-based painkillers such as oxycodone has skyrocketed as well. In 2013, 71.3 percent of prescription drug overdoses involved opioid painkillers, according to the Centers for Disease Control and Prevention.
"Combating the opioid abuse epidemic is a top priority for the FDA," said Dr. Stephen Ostroff, M.D., acting commissioner of the FDA, in a press release. "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."
Narcan is the first FDA-approved nasal spray, although the agency reports the widespread use of unapproved kits that combine the injectable form of the drug with an atomizer.
The drug can be used with adults or children by spraying it into one nostril while the overdosing patient is laying on their back. Naloxone can counter an overdose in a few minutes if administered quickly, and the FDA cautions that people who overdose should be seen by medical professionals, even if given the drug.
Last year, the cost of naloxone doubled from $15 per dose to more than $30, with some reports of the price rising as high as $65. Seamus Mulligan, chief executive of Adapt, the company that manufactures Narcan, said the drug would carry a "public interest" price of $37.50 for one dose or $75 for a package of two for agencies and emergency medical services.
"We are making sure this is priced in a way that is responsible," Mulligan told STAT. "We have watched as the noise level and price for naloxone has been ramping up."
The public interest price is a discount negotiated with the Clinton Health Matters Initiative, intended to help public health and medical organizations get the drug.
"We believe that the partnership and pricing agreement with Adapt will assist us in helping organizations across the United States to save lives by making naloxone more affordable and accessible for those who need it most," said Rain Henderson, chief executive of the initiative, which is part of the Clinton Foundation, in a press release.
