A critical drug used to reverse opioid overdoses will now be sold as a nasal spray, a development that will likely broaden use of the antidote among family members and friends of addicts caught up in a growing national epidemic of drug abuse.
The Food and Drug Administration approved the spray form of naloxone Wednesday. Naloxone has been an effective lifesaver when quickly administered to addicts overdosing on heroin or prescription painkillers. Until now, the only approved versions of the drug have been injections that people without medical training were often reluctant to use.
“This easy-to-use intranasal formulation will no doubt save many lives,” Nora Volkow, director of the National Institute on Drug Abuse, said in a statement. The FDA expedited its review of the nasal spray, taking less than four months to approve it.
Federal health officials have pushed for the development of the spray as the country’s opioid crisis has worsened. In 2013, nearly 25,000 people died from overdoses of heroin and prescription painkillers such as OxyContin, according to the Centers for Disease Control and Prevention. The CDC has cited the expanded use of naloxone as one of the most important ways to respond to the heroin epidemic. Deaths from heroin overdoses increased 286 percent between 2002 and 2013.
Health officials hope the nasal spray will make it so easy to administer the drug that friends, family members, and members of the general public will be able to render quick aid to overdose victims. The nasal spray requires only a simple push of a button and there is no assembly of parts involved.
Emergency responders have also pushed for a nasal spray: Not only is it simpler to administer, but it also eliminates the risk of being pricked by a contaminated needle. In some cities, emergency workers have been using adapters placed on the tip of the syringe to convert the injectable into a spray.
The new nasal spray product will be sold by a unit of Adapt Pharma, a Dublin-based company that will market the product under the brand name Narcan. The nasal spray should be available in a matter of weeks, said Adapt Chief Executive Seamus Mulligan. The spray will have a “public interest price” of $37.50 for a single unit and $75 for a package of two for entities such as government Medicaid programs that insure low-income people, emergency medical services, and public health organizations, he said. He would not disclose the list price for other purchasers, such as those using private health insurance, but said it would be comparable after taking into account copayments and other discounts.
“We are making sure this is priced in a way that is responsible,” Mulligan said. “We have watched as the noise level and price for naloxone has been ramping up.”
Last year, public health agencies and emergency responders complained of a sudden and rapid increase in the price of naloxone as the opioid crisis intensified. Massachusetts Attorney General Maura Healey’s office said the wholesale price of naloxone doubled from less than $15 a dose to more than $30 in late 2014. Some first responder agencies reported paying as much as $65 for a single unit of the drug. In August, Healey’s office reached an agreement with naloxone manufacturer Amphastar Pharmaceuticals (AMPH) to pay $325,000 to a state fund used to purchase the drug.
A second company, Indivior, is also seeking approval from the FDA for a nasal spray version of naloxone.