First-of-its-kind drug sanctioned to reverse effects of heroin or oxycodone use
THURSDAY, Nov. 19, 2015 (HealthDay News) — Narcan (naloxone hydrochloride) nasal spray has been approved by the U.S. Food and Drug Administration to stop or reverse an overdose of opioids.
Narcan, if given soon enough, can reverse the effects of an overdose in as little as two minutes, the agency said. The drug was approved previously as an injection. However, many first responders believe a nasal spray is easier to deliver and avoids the possibility of needle contamination, the FDA said. The drug is not meant to substitute for immediate medical care.
In clinical testing, the nasal spray given in one nostril had about the same effectiveness as the drug’s injected form, the FDA said. If the drug is given to people who are dependent on opioids, they may develop symptoms of severe opioid withdrawal, including body aches, diarrhea, rapid heartbeat, fever, runny nose, and sneezing, the agency said.
“Combating the opioid abuse epidemic is a top priority for the FDA,” Stephen Ostroff, M.D., acting commissioner at the FDA, said in a statement. “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 nasal spray is distributed by Adapt Pharma, based in Radnor, Pa.