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Narcan (naloxone HCl) Nasal Spray 2mg Approved by U.S. Food and Drug Administration

January 25, 2017 – Dublin, Ireland – Today, the U.S. Food and Drug Administration (FDA) approved Narcan Nasal Spray as a 2mg formulation for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. The 2mg dose is approved for use in opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.

This approval comes just over one year after the FDA approved the first-of-its-kind, ready-to-use, needle-free version of naloxone, Narcan Nasal Spray 4mg, which has been commercially available since February 2016 following expedited FDA review and approval.

Narcan Nasal Spray 2mg and 4mg are concentrated naloxone nasal sprays providing ready-to-use emergency treatments of opioid overdose, including prescription opioid painkiller-, fentanyl-, carfentanil- and heroin-related overdose. Narcan Nasal Spray is not a substitute for emergency medical care.

About Narcan (naloxone HCl) Nasal Spray

Narcan Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Narcan Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

Narcan Nasal Spray is not a substitute for emergency medical care. Always seek emergency medical assistance in the event of a suspected, potentially life-threatening opioid emergency after administration of the first dose of Narcan nasal spray.

If the desired response is not obtained after 2 or 3 minutes, administer an additional dose of Narcan Nasal Spray in an alternate nostril using a new Narcan Nasal Spray. If the patient responds to Narcan Nasal Spray and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose and continue surveillance of the patient. If there is still no response and additional doses are available, administer additional doses of Narcan Nasal Spray every 2 to 3 minutes using a new Narcan Nasal Spray in alternate nostrils with each dose until emergency medical assistance arrives. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

Availability of Narcan Nasal Spray

Narcan Nasal Spray 4mg was launched in February of 2016 and is widely available. Adapt will provide further information on access and availability of the newly approved 2mg strength upon its launch.

Qualifying group purchasers may source Narcan Nasal Spray 4mg directly from wholesalers and distributors. To place a pre-order immediately or for assistance in sourcing Narcan Nasal Spray please contact Adapt Pharma’s dedicated Customer Service Team at 844-4-NARCAN® (844-462-7226) or email customerservice@adaptpharma.com.

About Adapt Pharma

Adapt Pharma is a privately-held pharmaceutical company committed to positively impacting the lives of patients. Adapt Pharma’s strategy is to identify, evaluate, selectively acquire and enhance the value of late stage development, and FDA approved, pharmaceutical products. Adapt Pharma’s company headquarters is in Dublin, Ireland and its U.S. headquarters is in Radnor, Pennsylvania. For more information, please visit www.adaptpharma.com.

Source: Adapt Pharma

Posted: January 2017

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