The FDA approved the first over-the-counter Narcan (naloxone) product on March 29.
The approval follows an independent panel voting 19-0 in support of allowing for the product that reduces or reverses opioid overdoses to be given the OTC stamp.
Northwell Health's Sandeep Kapoor, MD, told Becker's the decision is "monumental."
"Making this over-the-counter, what you're really doing is opening up the dialogue that this is a serious healthcare crisis and everybody has some power in the equation," Dr. Kapoor, assistant vice president of emergency medicine addiction services for the New Hyde Park, N.Y.-based system, said.
He compared naloxone to first-aid kits in homes and defibrillators in malls but said some barriers persist, including stigma and the cost of Narcan.
There is a big margin between the manufacturing cost and what hospitals pay for the drug, Dr. Kapoor said. Intranasal naloxone kits can cost between $22 and $60, according to the Bureau of Justice Assistance. In a news release, the FDA said the manufacturer of Narcan 4 milligram naloxone hydrochloride nasal spray — Emergent BioSolutions — will determine the availability and price.
"Today's action paves the way for the lifesaving medication to reverse an opioid overdose to be sold directly to consumers in places like drugstores, convenience stores, grocery stores and gas stations, as well as online," the FDA said.