Media Campaign Launched to Raise Awareness of NARCAN® Nasal Spray

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Sep 24, 2018, 07:00 ET

Highlights how family and friends of those using opioids can be prepared for an opioid emergency

DUBLIN, Sept. 24, 2018 /PRNewswire/ -- ADAPT Pharma (ADAPT) today launched a pilot media campaign in eight designated market areas in the U.S. to increase awareness of the life-saving potential of NARCAN^® (naloxone HCl) Nasal Spray 4mg for people in the community who may witness an accidental opioid overdose. Friends and family members are encouraged to be prepared to respond to an opioid emergency by obtaining NARCAN^® Nasal Spray, which is covered by most health insurance¹ and available from major retail pharmacies without a prescription from a doctor².

According to a U.S. Centers for Disease Control and Prevention report, witnesses who could have potentially intervened were present during 44 percent of opioid overdose deaths, but rarely administered naloxone.³ Recognizing an important unmet need for education, U.S. Surgeon General Jerome Adams issued an opioid overdose and naloxone advisory in April, calling on patients, their loved ones and the public to learn the signs of an overdose and to talk with a doctor or pharmacist about getting naloxone.⁴ ADAPT's pilot initiative heeds this call to action.

"An accidental opioid overdose can happen at any time to those taking opioids, especially at higher doses," said Seamus Mulligan, Chairman and CEO of ADAPT. "Our new educational media campaign encourages friends and family members of those taking prescription opioids to take steps to be prepared to respond to a loved ones' opioid overdose emergency by obtaining NARCAN^® Nasal Spray, an emergency treatment for a known or suspected overdose."

In the United States, 50 states have access laws for naloxone in place, including NARCAN^® (naloxone HCl) Nasal Spray, and allow it to be purchased directly from a pharmacist without an individualized prescription from their doctor.² NARCAN^® Nasal Spray is covered by insurance plans for 97 percent of people in the U.S. with health insurance,¹ and 76 percent of dispensed prescriptions have a co-pay of $10 or less.⁵

ADAPT's Direct-to-Consumer advertisement will air in Augusta, GA.; Birmingham, AL.; Charlotte, NC; Jacksonville, FL.; Oklahoma City, OK; Pittsburgh, PA; Salt Lake City, UT; and Tucson, AZ.

NARCAN^® Nasal Spray 4mg is the first and only FDA-approved, needle-free formulation of naloxone for the emergency treatment of a known or suspected opioid overdose. It does not require assembly or any specialized medical training^* and is also the highest concentrated dose of intranasal naloxone currently available. NARCAN^® Nasal Spray is not a substitute for emergency medical care, and additional doses of NARCAN^® Nasal Spray may be required until emergency medical assistance arrives. Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance. Repeat doses may be necessary.

*See Instructions for Use

Please see Indications and Important Safety Information below.

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.

Important Safety Information

NARCAN^® (naloxone HCI) Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.

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, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include convulsions, excessive crying, and hyperactive reflexes. Monitor for the development of opioid withdrawal.

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.

Adverse Reactions: 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.

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.

Please see full Prescribing Information at: https://www.narcan.com/static/NARCAN-Prescribing-Information.c22dd4e5.pdf.

For additional information on NARCAN^® Nasal Spray, please visit www.NARCAN.com.

For questions regarding NARCAN^® Nasal Spray distribution, please call 1-844-4NARCAN (462-7226).

ABOUT ADAPT PHARMA^®Adapt Pharma^® is a privately-held company committed to expanding affordable access to NARCAN^® (naloxone HCI) Nasal Spray and to progressing treatment options in the field of addiction. Adapt Pharma's company headquarters is in Dublin, Ireland with U.S. headquarters in Radnor, Pennsylvania. For more information, please visit www.adaptpharma.com.

¹ MMIT Formulary Analytics. Accessed August 2018.
² Naloxone Overdose Prevention Laws. PDAPs. http://pdaps.org/datasets/laws-regulating-administration-of-naloxone-1501695139. Published July 1, 2017. Accessed September 18, 2018
³ Mattson CL, O'Donnell J, Kariisa M, Seth P, Scholl L, Gladden RM. Morbidity and Mortality Weekly Report (MMWR). Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/volumes/67/wr/mm6734a2.htm. Published August 30, 2018. Accessed September 18, 2018.
⁴ Adams J. Surgeon General's Advisory on Naloxone and Opioid Overdose. SurgeonGeneral.gov. https://www.surgeongeneral.gov/priorities/opioid-overdose-prevention/naloxone-advisory.html. Published April 5, 2018. Accessed September 18, 2018.
⁵ IMS Health, NPA Extended Insights Audit, AUG 2017 – JUL 2018. Specified Co-pay on dispensed prescriptions. Accessed August 2018.