Naloxone price increases may threaten public safety

A price increase for a popular form of the medication, naloxone, threatens the ability of non-profit programs and organizations, including police departments around the country, to provide a medical antidote for drug overdoses. 

Naloxone was first developed in the 1960s and is an opioid antagonist used to reverse potentially fatal respiratory depression in a person who has overdosed on opioid pain relievers or heroin. It can be administered using a needle injection or with an atomizer to create a nasal spray.

Naloxone has long been an inexpensive generic; however, a dramatic rise in prescription opioid and heroin abuse has increased the demand and subsequently the price of the drug.

“Many communities across the country are reporting an increase in opioid overdoses,” according to John Santilli, of Access Market Intelligence, which provides market intelligence to the pharmaceutical and healthcare industries. “Medical directors see a common pathway for people who have opioid addiction to use heroin because it is less expensive and easy to access.”

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Nasal naloxone is increasingly being distributed by state health departments and local community groups, who train users and friends or family to administer the drug in the case of an overdose. Most programs prefer the nasal naloxone because it is more user-friendly for those who may be uncomfortable handling needles. In addition, many programs provide the drug free of charge, which is also complicated by the price increase.

Several police departments across the country have also begun outfitting their officers with the nasal naloxone to combat the increasing rate of drug abuse, and are frustrated by the price spike, according to a report from the New York Times.

One reason for the price increase is that only a few pharmaceutical companies sell naloxone products. Hospira is the only company to sell an injectable formulation and Amphastar's formulation, though it is “off-label,” is the only nasal product. Amphastar has announced that it will be doubling the drug’s price starting December 1. The increase in price of nasal naloxone from the lone manufacturer is having a large negative impact on the ability of community groups to pay for the drug. There is also a new auto-injector formulation of naloxone hydrochloride, Evzio, from Kaleo Pharmaceuticals, which retails for around $700.

“The increase in price of nasal naxolone from the lone manufacturer is having a large negative impact on the ability of community groups to pay for the drug,” Santilli said. “The price of a new auto-injector naloxone . . . is projected to also be expensive.”

“To keep naxolone affordable, it should not be burdened with regulatory obstacles and made available at a price similar to what it costs to produce,” Santilli added.

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An intranasal naloxone, developed by Daniel Wermeling, PharmD, of the University of Kentucky and co-developed by Reckitt Benckiser has been granted the FDA’s fast-track review status. If approved, it will be the only naloxone product FDA indicated for nasal administration to treat heroin and opioid overdose.

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.