A Retrospective Literature Review Published in Pain Management on Prescribing Naloxone for Opioid Overdose Intervention Highlights Opportunities to Expand Community Access to Help Reduce Fatalities

Findings demonstrated importance of a multi-faceted approach to the opioid epidemic

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Apr 25, 2018, 07:00 ET

DUBLIN, April 25, 2018 /PRNewswire/ -- A retrospective literature review, published today in Pain Management, examined prescription naloxone as a harm-reduction strategy and outlined opportunities to expand naloxone use more widely into the community to help reduce opioid overdose fatalities. Researchers used PubMed to identify English-language publications from January 2000 to October 2017 that discussed the practice of naloxone prescribing in clinical, addiction treatment, correctional facility and pharmacy settings. Funding for the review was provided by Adapt Pharma, Inc.

"Current literature provided documentation on the role of increased access to naloxone as a harm-reduction strategy – both for patients prescribed opioids for pain management and those using opioids illicitly," said lead author Robert B. Dunne, M.D., Associate Professor at the Wayne State University School of Medicine. "However, there is a need for greater provider awareness of these benefits and the availability of easy-to-use naloxone formulations."

Since 2000, the incidence of opioid overdoses has tripled, and deaths from opioid overdose have increased by 200 percent in the United States.¹

"Discussions with patients who may be at risk of an opioid overdose and prescribing NARCAN^® (naloxone HCl) Nasal Spray can be effective ways to help ensure a critical intervention tool is present in the event of an overdose," said Mike Kelly, President of U.S. Operations at Adapt Pharma. "We support increased access to naloxone, a potentially life-saving medication, and treatment models that operationalize recommendations from the American Society of Addiction Medicine (ASAM) and the American Medical Association (AMA) on opioid overdose prevention."

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.

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/pdf/NARCAN-Prescribing-Information.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 Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in drug and opioid overdose deaths — United States, 2000-2014. MMWR Morb Mortal Wkly Rep 64(50-51), 1378-1382 (2016).

SOURCE Adapt Pharma