Adapt Pharma submits NDS to Health Canada for Naloxone Nasal Spray

May 2, 2016

DUBLIN, IRELAND — Adapt Pharma Limited (“Adapt Pharma”) today announced that Health Canada have accepted for review Adapt Pharma’s New Drug Submission for Naloxone Hydrochloride Nasal Spray.

Naloxone has been used as the standard treatment for opioid overdose for over 40 years. It is currently approved by Health Canada in injectable formulations.

Health Canada recently revised the listing of naloxone on the Canadian Prescription Drug List to allow non-prescription use of naloxone for emergency use for opioid overdose outside hospital settings. It is expected that, if approved, Adapt Pharma’s Naloxone Nasal Spray will be available without a prescription in Canada.

About Naloxone Nasal Spray

Adapt Pharma is developing Naloxone Nasal Spray in Canada in response to calls for new easy-to-use formulations of naloxone for use in the communities and homes where the majority of overdose related deaths occur.

Seamus Mulligan, Chairman and CEO of Adapt Pharma, commented, “If Health Canada approves the product, Naloxone Nasal Spray would allow for the administration of naloxone – the standard opioid overdose treatment – in an easy to use, needle-free, nasal spray formulation. We believe this would represent an important new tool to quickly respond to an opioid overdose emergency with this potentially life-saving medicine.”

NARCAN® (naloxone hydrochloride) Nasal Spray was recently approved and launched in the U.S. as the first FDA approved nasal spray version of naloxone hydrochloride. Adapt Pharma in-licensed the development program from Opiant Therapeutics, Inc. Adapt Pharma completed development of the product for the U.S. and submitted the NDA to the FDA, with approval received from the FDA in November 2015.

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. 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 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.

See Instructions for Use and full prescribing information in the use of this product, available here: https://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.