Adapt Pharma Partners with OH Attorney General DeWine to Guarantee Public Interest Price

December 1, 2016

Columbus, OH – Ohio Attorney General Mike DeWine announced an agreement on Friday, 11/25/16 with Adapt Pharma to provide NARCAN® (naloxone HCl) Nasal Spray 4mg at a discounted rate to state police, first responders, state or local government agencies, and community-based organizations. The Public Interest Price will be guaranteed for one year to qualified purchasers who are eligible to purchase two 4mg doses of NARCAN® Nasal Spray for $75.00, when obtained directly from Adapt in quantities greater than 48 units. This is a 40 percent discount from the Wholesale Acquisition Cost (WAC) of $125.

“We are very excited to be working with Attorney General DeWine to improve access and affordability to NARCAN® Nasal Spray throughout the state of Ohio,” said Mike Kelly, President of U.S. Operations at Adapt Pharma. “By ensuring our Public Interest Price, we can equip all police, EMS, Firefighters and those on the ground close to the opioid epidemic with the highest dose of FDA approved nasal naloxone that was designed for community use to treat opioid overdoses.”

NARCAN® Nasal Spray 4mg is the first and only, FDA-approved naloxone nasal spray intended for use in the community setting to reverse the potentially fatal effects of an opioid-related overdose. It was developed in collaboration with the National Institute on Drug Abuse (NIDA) in order to provide a ready-to-use, needle-free product that delivers a concentrated naloxone dose to restore breathing quickly in the community setting. Naloxone is not a substitute for emergency medical care. Repeated doses may be necessary

“It’s critical that all naloxone devices provide an adequate and consistent dose of naloxone in a way that can be easily administered by a bystander or first responder in the home – a place where a majority of opioid overdoses are occurring,” said Dr. Shawn Ryan, Assistant Professor of Emergency Medicine at the University of Cincinnati, as well as President of the Ohio Chapter of the American Society of Addiction Medicine. “Providing a high dose, like 4 mg, can help to prevent unnecessary overdose deaths as more potent synthetic opioids plague Ohio communities. These drugs often require more naloxone in a shorter window of time.”

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.