BETHESDA, MD 09 Dec 2015—FDA on November 18 announced the first-ever approval of a naloxone hydrochloride product that delivers an intranasal dose of the opioid antagonist.
Narcan nasal spray will be available in pharmacies in early 2016, according to Adapt Pharma.
Labeling for the product states that it is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory or central nervous system depression, or both, in settings where opioids may be present.
Naloxone was first approved in 1971 and has long been available in formulations intended for injection. Overdose prevention programs have promoted the use of various kits that permit the intranasal administration of naloxone, but this has been an off-label use.
FDA stated that the approval of Narcan nasal spray gives first responders and caregivers access to an agency-approved opioid-reversal product that is easier to deliver than injectable formulations and eliminates the risk of a contaminated needlestick injury.
The new product from Adapt Pharma consists of a sprayer that delivers a 4-mg dose of naloxone through a nozzle after a single press on the plunger. The device should not be primed before use. Two sprayers are provided in each carton of the product.
FDA emphasized that naloxone is not a substitute for medical care and that medical attention should be sought on behalf of the patient after the administration of the opioid antagonist.
Patients are at risk for severe opioid withdrawal symptoms, including adverse cardiovascular events, after the administration of naloxone and require monitoring for such events, according to the labeling.
The labeling also includes warnings about the potential need for repeated administration of naloxone if the initial dose wears off and the symptoms of the opioid overdose resume. The labeling also states that the standard dosage of naloxone may be only partially effective for the reversal of central nervous system depression caused by an overdose of buprenorphine, pentazocine, or other partial opioid agonists or mixed opioid agonists and antagonists.
Adapt Pharma stated that it has entered into partnerships to make its nasal spray product available to law enforcement, first responders, health departments, school districts, and other community-based group purchasers. The company stated that it also expects the product to be broadly covered by health insurers.
United Kingdom–based Indivior Inc. is also seeking FDA approval to market an intranasal formulation of naloxone. Indivior announced on November 24 that FDA determined that the company's proposed product did not meet the agency's expectations for early-stage uptake of the drug. The company stated that it is evaluating its options for addressing FDA's concerns.