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.