FDA clears new, easy-to-use version of heroin antidote

Staff Writer
Columbus CEO

WASHINGTON (AP) — The Food and Drug Administration has approved an easy-to-use version of the life-saving drug that reverses heroin and prescription painkiller overdoses, as communities across the country grapple with a wave of drug abuse.

The reformulated drug, sold as Narcan, comes as a nasal spray and should help first responders, police and others deliver the antidote in emergency situations. Known generically as naloxone, the drug reverses the effects of opioids — drugs that include legal painkillers such as oxycodone and illegal narcotics such as heroin.

Government officials from the White House to the local level have called prescription opioid abuse a "national crisis," tied to more than 16,000 deaths in 2013. Another 8,000 additional deaths involved heroin, which many addicts switch to after becoming addicted to more-expensive legal drugs.

Increasing access to naloxone has become a key tool in efforts to curb overdoses.

Officials across the country have begun handing out the drug to police, drug users and families of addicts, though the increased demand has driven up prices from the handful of companies that offer naloxone.

The nasal spray from Adapt Pharma has the potential to help lower prices.

The Irish company said it will price Narcan at $37.50 per dose for all government, community and educational organizations, including law enforcement, fire departments and schools. That compares to prices ranging from $75 to $100 for existing injectable versions of the drug, though many buyers negotiate discounts.

"We want to have broad access across the U.S.," Seamus Mulligan, Adapt's founder and chief executive, said in an interview with The Associated Press. "That's the approach we're taking in terms of pricing and transparency."

Some first responders already convert naloxone injections into a nasal spray using nozzles and other equipment. But Mulligan says his company's spray container delivers the same dose of the drug with a fraction of the liquid used in injections.

"It's ready to use, it's simple, it's just one push and you've delivered your therapeutic dose," Mulligan said.

Narcan will be available nationwide at pharmacy chains such as CVS Health, mainly with a prescription from a health care professional. Fifteen states allow the drug to be sold without a prescription, including California, New Jersey and Utah.

Wall Street analysts estimate nasal-spray naloxone could garner annual sales of $25 million in the U.S. The new product will compete with older injections from Amphastar Pharmaceuticals and a pen-like injector device called Evzio, from Kaleo Inc., that usually sells for several hundred dollars.