DUBLIN, April 26, 2018 /PRNewswire/ -- Adapt Pharma® (Adapt) (adaptpharma.com) welcomes the Surgeon General and National Council for Behavioral Health (National Council) for highlighting the need to make naloxone available to members nationwide that provide residential treatment for opioid use disorder. Adapt is donating 20,000 doses of NARCAN® Nasal Spray (10,000 boxes) and educational materials to ensure people supporting those in treatment have the materials they need to educate those who suffer from substance use disorder.
"Adapt Pharma® welcomes the comments from the U.S. Surgeon General Dr. Jerome Adams at the NatCon18 to ensure all patients that are seeking treatment are aware of the risks of opioid use and the vital importance of being prepared with naloxone," said Mike Kelly, President of U.S. Operations at Adapt.
The National Council follows recommendations from the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Centers for Disease Control (CDC) whereby patients seeking treatment be counseled on and prescribed naloxone. These guidelines are critical for those in treatment and especially important for family members and loved ones helping those who suffer from Substance Use Disorder (SUD).
NARCAN® Nasal Spray is an emergency opioid overdose treatment commonly available for community use, allowing family members and loved ones to become first responders in the event of an overdose. Patients, their family members and others close to them, are urged to talk with their pharmacists or doctors about having naloxone available wherever an opioid is present. State laws may vary.
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.
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 HCl) 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.
ABOUT ADAPT PHARMA® Adapt Pharma® is a privately-held company committed to expanding affordable access to NARCAN® (naloxone HCl) 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.