FDA approves overdose-reversal device for home use

LOS ANGELES - With opioid drugs, mainly prescription painkillers, responsible for more than 16,000 deaths and half a million emergency room visits a year, the government on Thursday approved the sale of a handheld "rescue pen" that caregivers or family members can use to avert a potentially fatal overdose.

The Food and Drug Administration said it cleared the prescription auto-injector to deliver naloxone - the same non-narcotic drug that paramedics and ER doctors use - nearly three months ahead of schedule and after just 15 weeks of deliberation under so-called priority review.

The device, to be marketed under the commercial name Evzio and produced for the Richmond, Va., firm Kaleo Inc., is modeled on devices like those that deliver epinephrine to patients with anaphylactic reactions, or insulin to diabetics.

Like an automated external defibrillator, however, the Evzio kit also provides verbal instruction in the use of the injection for caregivers or family members who recognize the dangerously slowed heartbeat, depressed respiration and loss of consciousness that suggests someone taking opioids has overdosed. A training device allows caregivers and family members to practice emergency administration of 0.4 mg. of naloxone, which can be injected into muscle or just under the skin.

The device could not have saved Kacie Rumford, 23, who died of a heroin overdose, alone in her bedroom in the family's Kennett Square home on March 12, 2013. But opioid overdoses take hours to become fatal, and addicts often use together.

"If I had this I'd be walking around with this thing in my pocket," said Andy Rumford, who found his daughter on her bed, a needle next to her arm.

Making this product available for use beyond an ambulance or hospital "could save lives by facilitating earlier use of the drug in emergency situations," said Bob Rappaport, director of the division of anesthesia, analgesia, and addiction products at the FDA's Center for Drug Evaluation and Research.

How much it is used will depend to some extent on cost, which had not been determined, and whether health insurance will cover it.

The prescription painkiller epidemic spans all social classes, with the largest growth in recent years among white suburbanites. But it has spurred a parallel increase in heroin addiction, as users of pills require larger doses and discover that heroin is a fraction of the cost. The downward spiral of heroin addiction can leave users penniless.

The use of Evzio is not without risks. Among the opioid-dependent, a shot of naloxone can cause sudden and severe opioid withdrawal, which can cause nausea, vomiting, accelerated heart rate, increased blood pressure, seizures, and cardiac arrest. Repeat doses may be needed, as opioids can outlast naloxone's reversal effects, and the FDA cautioned that Evzio is not a substitute for emergency medical care.

But naloxone, also known by the brand-name Narcan, is considered relatively safe and non-addicting. If it is mistakenly used to treat something other than an opioid overdose, experts say, it will have almost no effect at all. (Other medical treatment would be needed; regulators say people whose overdoses are reversed using naloxone also should get followup medical treatment.)

The FDA's approval of Evzio was billed by the agency Thursday as part of a two-pronged approach to addressing opioid drug abuse, an epidemic that has overtaken automobile crashes as the leading cause of injury death in the United States.

In recent years, the agency has sought to reduce the abuse potential of opioid analgesics and tightened rules on the prescribing of opioid pain relievers. But the FDA recently approved marketing of a new extended-release opioid painkiller, Zohydro, in a formulation that activists, emergency physicians, and the agency's own advisory panel have warned could be diverted and misused.

Such decisions, FDA Commissioner Margaret Hamburg said Thursday, aim to "ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain."

In a statement released alongside the approval of the naloxone rescue-injector, Hamburg called the goals of reducing opioid abuse while preserving patients' access to pain relief "compatible," and said that "actions to address one should not be at the expense of the other."

"While the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse, they are extremely important innovations that will help to save lives," Hamburg said in a statement.