Adapt Pharma Presents Human Factors Study Data at 2017 International Conference on Opioids

DUBLIN, June 12, 2017 /PRNewswire/ -- Adapt Pharma today presented findings from two human factors studies conducted, as a part of U.S. product approval, to evaluate the usability of NARCAN® Nasal Spray by adolescents and individuals including those with low literacy. The poster, titled Usability of Naloxone Nasal Spray By Age and Literacy Level: A Pooled Analysis of Human Factors Studies, was presented at the annual International Conference on Opioids (ICOO) at Harvard Medical School in Boston, MA.

"The study demonstrated that ready-to-use, intranasal naloxone can be used by a layperson to administer this drug to those experiencing an opioid-related overdose," said Melissa Beck, B.A, the poster's lead author.

The data demonstrated that, without instruction or training, a cross section of the population (adults and adolescents, normal and low literate) can complete the critical steps necessary to properly deploy NARCAN® Nasal Spray in simulated emergency situations. The data also demonstrated that the understanding of key concepts in the Patient Information was high among study subjects regardless of age or literacy level. Results suggested that NARCAN® Nasal Spray can be administered by a bystander population with no training or advanced review of product instructions. 

It is important to note that while this study was conducted to evaluate the usability of NARCAN® Nasal Spray, Adapt Pharma always recommends that individuals review and have a complete understanding of the Patient Information and the Instructions for Use for NARCAN® Nasal Spray.

"As the opioid epidemic evolves, we are seeing a growing need to prepare and equip all populations with tools to help their loved ones, neighbors and community members," said Mike Kelly, President, U.S. Operations, Adapt Pharma. "This study offers additional insight into how community members can utilize NARCAN® Nasal Spray for the treatment of a known or suspected opioid overdose while waiting for emergency help to arrive."

NARCAN® Nasal Spray is the first and only FDA-approved naloxone in a nasal spray for the emergency treatment of opioid overdose. It is available as a ready-to-use, needle-free, 4 mg dose of naloxone in a single spray. NARCAN® Nasal Spray is not a substitute for emergency medical care, and repeat applications may be necessary.  Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.  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.

AVAILABILITY OF NARCAN® NASAL SPRAY

NARCAN® Nasal Spray 4mg was launched in February of 2016 and is widely available. NARCAN® Nasal Spray 2mg has been approved by the Food and Drug Administration (FDA) on Jan. 25, 2017 and Adapt will provide further information on its commercial availably when details are confirmed.

Qualifying group purchasers may source NARCAN® Nasal Spray 4mg directly from wholesalers and distributors. To place an 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, fever, sweating, runny nose, sneezing, goose bumps (piloerection), yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure and increased heart rate (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 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 full Prescribing Information, Patient Information, and Instructions for Use of this product, available here: http://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf.

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.

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SOURCE Adapt Pharma