Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Narcan Nasal Spray 2mg

Adapt Pharma news release; 2017 Jan 25

The US Food and Drug Administration (FDA) approved NARCAN Nasal Spray (naloxone HCI) as a 2mg formulation for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Indications: NARCAN Nasal Spray 2mg is a concentrated naloxone nasal spray providing ready-to-use emergency treatments of opioid overdose, including prescription opioid painkiller-, fentanyl-, carfentanil- and heroin-related overdose. It is not a substitute for emergency medical care.

Dosage/administration: Administer a single spray of NARCAN Nasal Spray to adults or pediatric patients intranasally into 1 nostril. Administer additional doses, using a new nasal spray with each dose. If the patient does not respond or responds and then relapses into respiratory depression, additional doses may be given every 2 to 3 minutes until emergency medical assistance arrives.

Adverse reactions: The following adverse reactions were observed in a NARCAN Nasal Spray clinical study: increased blood pressure, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, and nasal inflammation.

Citation:

NARCAN (naloxone HCl) Nasal Spray 2mg approved by U.S. Food and Drug Administration (FDA). Adapt Pharma Web site. January 25, 2017. http://adaptpharma.com/adapt_press_release/january-25-2017-narcan-nasal-spray-2mg-approved-by-us-food-and-drug-administration/ Accessed January 27, 2017.

Must Reads in FDA Actions

FDA Approves Ajovy for Migraine in Adults, Teva Pharmaceutical news release; 2018 Sep 14

FDA Approves Tiglutik for Treatment of ALS, ITF Pharma news release; 2018 Sep 6

FDA Approves Diacomit for Treatment of Seizures, Biocodex news release; 2018 Aug 23