Our Focus

Opioid Overdose

The Epidemic

Accidental drug overdoses, including those involving opioids, are a leading cause of accidental deaths in America.

  • In 2014, opioid overdoses claimed over 29,000 lives – an average of one every 17 minutes. 
  • In 2011, there were an estimated 488,004 emergency department visits involving non-medical use of opiates or opioids.

According to Nora D. Volkow, Director of the National Institute of Drug Abuse (NIDA), accidental opioid overdose is a “public health epidemic with devastating consequences.”

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The Human Cost

This epidemic affects all layers of American society, without regard to geography, age, race, or socioeconomic status. By 2013, unintentional drug poisoning was the leading cause of accidental death in the United States. The consequences are not only national, but also deeply personal: deaths from accidental opioid overdose send out tidal waves of pain through families and friends, leaving a deep and enduring sense of loss.

Collaborative Response

Because accidental overdose is such a far-ranging public health problem, it’s important that everyone from parents to providers to policymakers work together to save lives. Fortunately, there is a growing chorus of voices that recognize the seriousness of this problem and are calling for measures to address this epidemic.

On the federal, state, local, and advocacy levels, key stakeholders have been developing policies and practices to help prevent accidental opioid-related overdoses and deaths, 76% of which occur outside medical settings and 56% of which occur in homes.

Working with NIDA to develop needed products and under the US Food and Drug Administration’s (FDA) Fast Track Designation and Priority Review process, Adapt Pharma is helping address accidental opioid overdose fatalities in America.

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® 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.

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.