FDA approves user-friendly device to reverse opioid drug overdoses

Family, friends or passersby who encounter a person passed out from a heroin or other opioid overdose may soon be able to administer a drug to reverse the effects themselves before waiting for first responders to arrive. The US Food and Drug Administration announced on Thursday the approval of an auto-injector device, called Evzio, to administer naloxone hydrochloride. It can be carried in a pocket or stored in a medicine cabinet and will be available by prescription this summer.

“This is an extremely important innovation that will save lives,” FDA Commissioner Dr. Margaret Hamburg said in announcing the approval.

It comes a week after Governor Deval Patrick declared a public health emergency to combat the growing abuse of opiates and recent spike in heroin deaths in the state; his declaration allows police and other emergency personnel to carry Narcan, a form of naloxone administered as an injection or formulated into a nasal spray (which is not FDA approved).

Health officials in Massachusetts began distributing the nasal spray in 2006 to those most likely to witness an overdose, including outreach workers, homeless shelter operators, addicts themselves, and more recently, family members. The program, which started in Boston, has been credited with reversing more than 1,800 overdoses from heroin, prescription painkillers, and other opiates. But its availability remains limited.

Doctors will be able to prescribe Evzio to anybody living in a setting where an opioid overdose can occur -- even if that patient isn’t at risk of overdosing, according to Dr. Douglas Throckmorton, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research. Parents, for example, could keep the auto-injector on hand if they’re taking oxycodone for cancer pain and are worried about a young child accidentally ingesting it; they could also get a prescription if they know their teen is a heroin abuser.

Anyone who administers Evzio will be given specific audible instructions on how to use the auto-injector -- akin to those delivered by portable defibrillator devices for people in cardiac arrest -- and overdose signs to look for such as decreased breathing or heart rate and a loss of consciousness.

“It’s not meant to replace all the naloxone products already out there, but it will certainly add to the arsenal,” said drug policy researcher Leo Beletsky, an assistant professor of law and health science at Northeastern University. He estimated that Evzio is likely to cost upwards of $200 a dose compared to $15 to $40 for the nasal spray, but Kaléo, Evzio’s manufacturer, said a price has not yet been determined.

While naloxone works only to reverse an overdose from heroin or other opioids, giving it to someone who has overdosed on alcohol or some other drug will have no harmful effect, Throckmorton said.

From 2000 to 2010, more than 100,000 Americans died from overdosing on prescription opioids, with a quadrupling in the death rate over the decade. “Prescription opioid deaths now outnumber those from illicit drugs including heroin and cocaine combined,” Kathleen Sebelius, secretary of the Department of Health and Human Services, said during the briefing.

A recent report on heroin deaths in Massachusetts has accelerated efforts to increase the use of naloxone. At least 185 people died from suspected heroin overdoses from November of last year through February, according to the State Police; the figure did not include the state’s three largest cities of Boston, Springfield, and Worcester.

Michael Botticelli, acting director of the Obama administration’s Office of National Drug Control Policy, pointed to a successful 2010 Quincy program that gave naloxone to first responders as a reason to make the drug more widely available to bystanders who may encounter drug overdoses. The program, he said during the briefing, reversed more than 200 overdoses.

In February, the Obama administration called on states to ease access to naloxone, and last month Ohio passed a “Good Samaritan” law allowing friends and family members of addicts to administer naloxone without any fear of getting arrested. Maine Governor Paul LePage, however, vetoed legislation in his state that would have made the drug more widely available, saying that it was too expensive and would encourage more drug addiction.

While highly effective, naloxone might prove tricky for consumers to administer. “It puts a person into sudden, acute withdrawal so they can become agitated and combative,” said Dr. Steven Kassels, medical director of Community Substance Abuse Centers, in Westfield, Mass. Withdrawal symptoms also include vomiting, sweating, and a rapid heartbeat, or even seizures and cardiac arrest.

On the flip side, the drug’s ability to reverse the effects of an opioid overdose depends on the dose and type of drug taken, so repeat doses may be needed, according to the FDA. For this reason, the agency urged anyone who used Evzio to call for emergency help immediately after the injection is administered.

Some local policy makers have accused the federal government of contributing to the drug-abuse problem by approving a growing number of addictive painkillers without appropriate safeguards to keep doctors from over-prescribing them.

Patrick, as part of his emergency declaration, prohibited the sale of a highly-criticized narcotic painkiller called Zohydro, which was approved by the FDA last year. The pill, which contains an extended release form of hydrocodone, is not tamper-resistant, which means it can be crushed, injected, and more easily abused.