The rising death toll from opiate overdose in the U.S.—almost 17,000 involved prescription painkillers and 3,000 involved heroin in 2010, according to the CDC—has public health officials looking for an antidote.
There actually is one. The drug called naloxone is a kind of emergency break for overdose: it can stop and reverse an overdose from opioids like morphine, heroin, and oxycodone. And between 2006 and 2010, it stopped 10,171 overdoses after having been distributed to 53,032 people, according to the CDC. Approved by the FDA in 1971, naloxone has historically been used in hospitals and emergency rooms. But a recent push from government officials and public health experts in New York and elsewhere is trying to make naloxone more available, putting the life-saving drug in the hands of first responders, community organization leaders and pharmacists. But bringing the drug to the ever growing number of patients at risk for opiate overdose—more than 12 million people reported using prescription painkillers non-medically in 2010, says the CDC, and another nearly 700,000 reported using heroin in 2012—is not going to be easy.
There are several barriers to getting this drug to patients outside the hospital, experts say. The issue is that filling a naloxone prescription can be quite difficult, depending on where a patient lives. That's because many doctors and pharmacists don't know they can prescribe naloxone outside of the hospital and because the drug is not always reimbursed by insurance companies, says Daniel Wermeling, a professor of pharmacy at the University of Kentucky College of Pharmacy, who is developing a nasal naloxone spray, which, if approved, would be the the first nasal spray approved for use in the U.S. "Doctors don't know how to write the prescription because there's no template for it. If they do send it to CVS or Walmart, the pharmacist wouldn't know what to do with it," Wermeling says.
Currently, 23 states and the District of Columbia have laws of varying types to make naloxone more widely available in communities. Rhode Island, for example, has created what is called a "collaborative practice agreement" with Walgreens, a hospital doctor, and the Board of Pharmacy so that patients can walk in to the pharmacy and get the drug without seeing a doctor first. Reports about the program say insurance companies have paid for the drug.
As of a couple of years ago, some 15 states also had community programs that distributed naloxone with pretty good success. But those groups have come up against another structural problem with naloxone: The small market means few manufacturers, leading to high prices and occasional shortages. "The cost is going up and the supply is unpredictable," explains Rain Henderson at the Clinton Health Matters Initiative at the Clinton Foundation, which is working to help bring together community groups and manufacturers to ensure a predictable and affordable supply of naloxone going forward.
And for reasons that aren't entirely clear, several naloxone manufacturers have dropped out of the market over recent years, leaving two companies, Hospira and Amphastar, as the only sources of the drug until very recently. This has led to past shortages and a rise in price for the drug, community groups say. Confidentiality agreements prohibit them from disclosing the price they pay for the drug.
These challenges, paired with the relatively small U.S. market for naloxone—roughly $25 million in US sales, says Wermeling, compared with more than $2.5 billion in sales for the prescription painkiller OxyContin—have not given many companies the incentive to start making it. But, in March, Mylan, a drug company in Pittsburgh, announced the launch of a naloxone injection. The FDA also recently approved an auto-injector naloxone devise called Evsio. The good news about this new product is that it creates a precedent for prescription for naloxone—people on high-dose opioids may leave the doctor's office with an Rx for this, in case of emergency—but it is also likely to be very expensive. Experts say it could cost up to $500.
Much still needs to happen across the country to get naloxone into more hands. Doctors will need to be better educated about how to prescribe, states and cities will need to remove regulatory barriers to getting the drug, and insurance companies will need to expand coverage. If all of these things happen, the sales might grow enticing more new manufacturers into the market. But that's far from certain, says Wermeling, who may soon enter the market if the nasal spray he is developing succeeds. "It is still an untested market. We are hopeful, but it is really an unknown."