New Data Presented on Adapt Pharma's Community Use of Narcan® Nasal Spray 4 mg to Reverse Opioid-Related Overdose

DUBLIN, March 16, 2017 /PRNewswire-USNewswire/ -- Adapt Pharma (www.AdaptPharma.com) today presented results of a survey conducted with Police and Community Organizations describing real-world experiences and outcomes with the FDA-approved 4mg naloxone nasal spray formulation (NARCAN®(naloxone HCI) Nasal Spray 4mg).  The poster, titled Use of Naloxone Nasal Spray in the Community Setting: a Survey of Use by Community Organizations, was presented at the annual American Academy of Pain Medicine (AAPM) in Orlando, Florida.

The survey collected case data and examined the outcomes of attempted opioid-related overdose reversals reported by first responders and community health organizations, where NARCAN® Nasal Spray 4mg was administered. Participating organizations provided data on several outcome measures including reversal outcomes, agents involved in overdose and observed events.

"Narcan® Nasal Spray 4 mg was approved under priority review by FDA and launched in February 2016.  We are pleased to have real-world experiences and outcomes with Narcan Nasal Spray presented at AAPM," said Seamus Mulligan, Chief Executive Officer of Adapt Pharma.  "Narcan Nasal Spray was designed to be administered in an emergency by people without specialized medical training."

The survey, conducted in August 2016, was designed and implemented by Synchrony Medical Communications, LLC. Data were generally collected via case report forms or company logs of the participating first responders and community health organization representatives. Real-world data evaluations are limited due to retrospective nature of the data and provider and reviewer biases.

NARCAN® Nasal Spray is the first and only FDA-approved naloxone in a nasal spray for the emergency treatment of opioid overdose. It is now available as a ready-to-use, needle-free, 4 mg dose of naloxone in a single spray. As the first and only FDA-approved naloxone nasal spray, NARCAN® Nasal Spray provides a ready-to-use alternative to currently available opioid overdose emergency treatments. 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.

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. 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 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 – 4mg

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^® 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.

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.

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NARCAN^® NASAL SPRAY INDICATIONS AND IMPORTANT SAFETY INFORMATION
Indications – 2mg

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 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.

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SOURCE Adapt Pharma