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

January 25, 2017

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

Adapt Pharma to provide 2mg as an additional dosing option for naloxone nasal spray

 

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. Please see Indications and Important Safety Information below.

 

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.

 

Please see Indications and Important Safety Information below. 

Please see full prescribing information for NARCAN® Nasal Spray, available at http://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf

 

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.

 

NARCAN® NASAL SPRAY INDICATIONS AND IMPORTANT SAFETY INFORMATION

Indications

NARCAN® (naloxone hydrochloride) Nasal Spray is an opioid antagonist 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.

 

Limitations of Use:

Restrict prescription of NARCAN Nasal Spray 2 mg to 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.

 

Important Safety Information

NARCAN® Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride.

Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

 

Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.

Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may be characterized by convulsions, excessive crying, and hyperactive reflexes. Monitor for the development of opioid withdrawal.

There are limited data to inform if the 2 mg dose of NARCAN Nasal Spray will avoid precipitation of severe opioid withdrawal in the setting of opioid dependence.  However, the 2 mg dose may not provide an adequate and timely reversal in persons who may be exposed to an overdose of a potent or very high dose of opioids.

Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.

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

 

See Instructions for Use and full prescribing information in the use of this product, available here: http://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf.

 

Additional information, including full prescribing information for NARCAN® Nasal Spray, and important safety information and instructions for use, is also available at www.NARCAN.com.

 

To report SUSPECTED ADVERSE REACTIONS, contact Adapt Pharma, Inc. at 1-844-4NARCAN® (1-844-462-7226) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

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.

 

MEDIA CONTACT INFORMATION

Thom Duddy
Executive Director – Communications
Adapt Pharma
thomas.duddy@AdaptPharma.com
484-431-8223