Adapt Pharma acquires NARCAN NDA and obtains license to the NARCAN® trademark

July 2, 2015

DUBLIN, IRELAND – July 2, 2015 – Adapt Pharma Limited (Adapt Pharma) announced today that it has obtained a license to the Narcan trademark and acquired the related Narcan (naloxone HCl injection) New Drug Application (NDA).

Narcan was the first naloxone product approved by the U.S. Food and Drug Administration (FDA) as a treatment for opioid overdose in 1971. Narcan has not been distributed under the brand name since 2009; however, the Narcan trademark retains very high brand recognition. It is estimated that over the past year, Narcan has been mentioned in media reports and searched on the internet approximately as frequently as naloxone, the generic name for Narcan. This high brand recognition is a valuable tool for public health communications, especially given the imperative to build deeper public awareness of treatment options for opioid overdose.

Adapt Pharma previously announced that it had commenced a rolling submission of an NDA to the FDA for a nasal spray formulation of naloxone, a drug intended to treat opioid overdose.

“Our goal in acquiring Narcan and submitting this name as part of our rolling NDA for naloxone nasal spray is to be able to use a recognized name for our potential new product. To help achieve public health goals, using a familiar name can facilitate acceptance and uptake by physicians, patients and caregivers,” said Seamus Mulligan, CEO of Adapt Pharma.

Use of the Narcan name is subject to FDA review and approval.

About Opioid Overdose

The number of opioid overdose related deaths continues to increase. Data from the U.S. Centers for Disease Control and Prevention (CDC) WONDER database indicates opioid overdose led to the loss of more than 24,000 lives in America in 2013, a four-fold increase since 1999. Additionally, the Drug Abuse Warning Network (DAWN), a public health surveillance system managed by the Substance Abuse and Mental Health Services Administration (SAMHSA), estimated that in 2011, there were more than 740,000 emergency department visits involving the non-medical use of prescription opioids and heroin. With the majority of opioid overdose related deaths occurring in a non-medical setting, there is a need for more user-friendly naloxone formulations suitable for use in the community by non-medically trained personnel.

About Adapt Pharma Limited

Adapt Pharma Limited is a privately held pharmaceutical company committed to positively impacting the lives of patients with specialist medical conditions. 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 are in Dublin, Ireland, with its U.S. headquarters in Radnor, Pennsylvania. For more information, please visit www.adaptpharma.com.

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.