WASHINGTON -- A nasal spray formulation of naloxone hydrochloride, to be sold as Narcan and indicated for emergency treatment of opioid overdose, won approval from the FDA late Wednesday.
It's the first non-injectable form of naloxone to be cleared for U.S. sale.
"Combating the opioid abuse epidemic is a top priority for the FDA," acting FDA Commissioner Stephen Ostroff, MD, said in a statement. "We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose."
In announcing the approval, the FDA said first responders have indicated that a nasal spray would be preferred over injectable forms because of the ease of administration and because it would eliminate risk of accidental needlesticks. Consequently, the agency said, many emergency responders have put together their own unapproved kits with atomizers along with injectable naloxone to deliver nasal spray.
"Now, people have access to an FDA-approved product for which the drug and its delivery device have met the FDA's high standards for safety, efficacy and quality," the FDA said. The manufacturer, Adapt Pharma of Radnor, Pa., said it would charge $37.50 per device (two to a $75 package) for group purchasers such as emergency departments and fire and police agencies buying directly from the company.
The Narcan device delivers 4 mg of naloxone, preferably while the patient is lying on his or her back. Clinical trials demonstrated that, when used as directed, blood levels of naloxone were similar to those achieved with FDA-approved naloxone injectors.
The FDA said use of the nasal spray requires no special training and called it an "important new alternative for family members," although pointing out "that it is not a substitute for immediate medical care, and the person administering Narcan nasal spray should seek further immediate medical attention on the patient's behalf."
One particular adverse effect can be expected from the treatment, the agency noted: onset of opioid withdrawal syndrome in patients with opioid dependency.