DUBLIN, Sept. 20, 2016 /PRNewswire/ -- A new study released in The Journal of Clinical Pharmacology finds that the newly Food and Drug Administration (FDA) approved intranasal (IN) formulation of naloxone, NARCAN® (Naloxone HCl) Nasal Spray 4mg, delivers approximately the same amount of naloxone as a 2mg Intramuscular (IM) injection. Plasma concentrations were detectible within 2.5 minutes after nasal spray and maximum concentration levels of NARCAN® Nasal Spray were achieved as rapidly as with the IM injection of naloxone. There were no differences in the safety profile of NARCAN® Nasal Spray naloxone compared to the IM injection of naloxone.
This study also supported the usability of NARCAN® Nasal Spray by the general public and found that vast majority of study participants were able to successfully perform the most critical steps to administer NARCAN® Nasal Spray, on the basis of the instructions for use without the need for any specialized device training.
"Based on these robust pharmacokinetic and human use studies, needle free NARCAN® Nasal Spray can provide first responders and lay persons in the community with a ready to use and potentially life-saving concentrated dose of naloxone," said Dr. William Morrone, Deputy Chief Medical Examiner and Chief Medical Officer for Recovery Pathways in Bay City, Corunna and Ortonville, Michigan.
"We are excited to have this data published; demonstrating the concentrated formulation in NARCAN® Nasal Spray 4mg achieving a rapid and effective exposure of naloxone. This is increasingly important due to the dramatic rise in overdose cases of highly potent opioids, such as fentanyl, which require higher concentrations of naloxone," said Seamus Mulligan, Chief Executive Officer of Adapt Pharma.
The 30-person pharmacokinetic study, which was supported in part by the National Institute on Drug Abuse (NIDA), compared the pharmacokinetic properties of intranasal naloxone (2 to 8 mg) concentrated in low volumes (0.1 to 0.2 mL) to an approved (0.4 mg) intramuscular dose. The study design was an inpatient, open-label, randomized, 5-period, 5-treatment, 5-sequence, crossover study.
A parallel study assessed the ease of use of this device in a simulated overdose situation in 116 members of the general public. 33 subjects were adolescents (aged 12 to 17 years), and 83 were adults (aged 18 years or older). A total of 59 (50.9%) had low literacy, and 57 (49.1%) had normal literacy.
The full study, Pharmacokinetic Properties and Human Use Characteristics of an FDA-Approved Intranasal Naloxone Product for the Treatment of Opioid Overdose, can be found here. The Digital Object Identifier (DOI) is 10.1002/jcph.759.
According to the U.S. Centers for Disease Control and Prevention (CDC), since 2000, the rate of deaths from drug overdoses has increased 137%, including a 200% increase in the rate of overdose deaths involving opioids. These deaths can occur anywhere at any time, especially with the dramatic rise of high potency opioids, such as fentanyl. It is important not only for opioid overdose reversal therapies to contain the appropriate concentration of naloxone, but to be usable by everyone, including adults and minors, that may find themselves witnessing an opioid overdose.
NARCAN® Nasal Spray is the first and only FDA-approved naloxone in a nasal spray for the emergency treatment of opioid, fentanyl and heroin-related overdose. It is now available as a ready-to-use, needle-free, 4 mg concentrated 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. 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 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 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 is available to individuals in leading retail pharmacies.
Qualifying group purchasers may source NARCAN® Nasal Spray 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 [email protected].
NARCAN® NASAL SPRAY INDICATIONS AND IMPORTANT SAFETY INFORMATION
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, 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.
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, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, and nasal inflammation.
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.
For Media Inquiries
Thom Duddy, Adapt Pharma
Executive Director, Communications
Email: [email protected]
SOURCE Adapt Pharma