Federal officials said Thursday they hoped a new "rescue pen" would help reduce the death toll from overdoses involving prescription painkillers.
Available until now only by syringe, naloxone has been a workhorse drug in emergency departments battling the relentless rise in painkiller overdoses over the last decade. Some communities also have experimented with making naloxone available as a nasal spray to first responders, such as paramedics and police officers.
But the FDA's blessing of the rescue pen, granted after a fast-tracked deliberation of just 15 weeks, marks the first time the medication will be available on a broad basis in a prefilled hand-held auto-injector that can be used by laypeople.
"Today's announcement will help make naloxone even more accessible," Michael Botticelli, acting director of President
A huge increase in the use of narcotic painkillers has been accompanied by a rise in addiction and overdoses, which are now responsible for more than 16,000 deaths each year. The surge in painkiller-involved overdoses has pushed drugs ahead of traffic accidents as a leading cause of death in the U.S. and prompted the
The rescue pen is part of a widespread campaign by public health officials, healthcare professionals and the pharmaceutical industry to find ways to promote the safe use of the drugs and reduce deaths.
A 2012 Times investigation of nearly 4,000 deaths involving prescription drugs in Southern California found that most victims overdosed at home, often with family members or friends nearby.
The rescue pen, to be marketed under the commercial name Evzio by the Richmond, Va., firm Kaleo Inc., is modeled on devices such as those that deliver epinephrine to patients with anaphylactic reactions, or insulin to diabetics. It delivers 0.4 milligrams of naloxone, which can be injected into muscle or just under the skin. Like an automated external defibrillator, the Evzio kit also provides instruction in the use of the injection.
Physicians who prescribe the pen can train caregivers and family members to recognize the dangerously slowed heartbeat, depressed respiration and loss of consciousness that suggests someone taking opioids has overdosed. The Times' examination of hundreds of coroners' reports found that loved ones often reported signs of an impending overdose, such as hearing an unusually loud snore from victims.
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 Dr. Bob Rappaport, director of the division of anesthesia, analgesia and addiction products at the FDA's Center for Drug Evaluation and Research.
The use of Evzio is not without risks. Among the opioid-dependent, a shot of naloxone can prompt 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. In fact, officials noted, the last instruction the pen gives is to call for medical help.
The FDA's approval of Evzio was billed by the agency Thursday as part of a multipronged approach to address the epidemic of painkiller addiction and overdose.
In recent years, the agency has sought to reduce the abuse potential of narcotic painkillers, also known as opioid analgesics, and tightened prescribing rules. However, 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
In a briefing, Hamburg called the goals of reducing opioid abuse while preserving 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," she said.