The rising number of opioid-related deaths in the U.S. has translated into big opportunity for pharmas selling the antidote med naloxone, with drugmakers such as Amphastar Pharmaceuticals ($AMPH) getting a sizable boost in revenue. But Amphastar has come under fire for repeated price increases--and it will soon face more competition, now that the FDA has cleared a nasal-spray version that will cost less.
The agency signed off on Adapt Pharma's Narcan, which is sprayed into one nostril to combat overdoses of prescription painkillers or heroin. Adapt said the drug will cost $37.50 per dose for government and community organizations, including police and fire departments, The Associated Press reports. Existing injectable versions of the drug run $75 to $100 per dose, the news service points out, so Adapt's treatment offers a sizable discount.
"We want to have broad access across the U.S.," Adapt CEO Seamus Mulligan told the AP. "That's the approach we're taking in terms of pricing and transparency."
The company plans to make Narcan available at pharmacy chains such as CVS Health ($CVS) with a prescription, although several states, including California and New Jersey, allow individuals to get naloxone without one.
FDA approval for Narcan comes at a critical moment as the opioid epidemic reaches new heights. Prescription opioid abuse was linked to more than 16,000 deaths in 2013, and another 8,000 deaths involved heroin, a cheaper option that many addicts choose once more expensive legal drugs become too costly. The agency signed off on Narcan in less than four months through its priority review program, "significantly ahead" of the January 2016 date it had laid out before, the FDA said.
"Combating the opioid abuse epidemic is a top priority for the FDA," FDA acting commissioner Stephen Ostroff said in a statement. "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."
The news will not sit well with Amphastar, which enjoys top-dog status in the naloxone market. The company saw a 41% jump in Q2 revenue from its naloxone drugs, even as it faces pushback over pricing.
Lawmakers have been railing against Amphastar for hiking the price of its injectable naloxone to $41 per dose in January 2015 from $19 per dose in June 2014. The price increases are interfering with distribution of the med, according to vocal pricing critics Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD).
Last year, New York Attorney General Eric Schneiderman sued Amphastar over rising naloxone prices, prompting the company to issue $6-per-dose rebates. Ohio Attorney General Mike DeWine also sued Amphastar, asking the company to repay $6 a dose after the drug's price climbed to $28.50 in October 2014 from $12.78 in 2013.
But Amphastar is not bowing under pressure. The company is moving forward with a ready-made naloxone nasal spray that it hopes will deliver an even bigger boost to its top line and set it apart from its competition.
- get the FDA's statement
- here's the AP story
- read Adapt's release