Adapt Pharma announced that the Food and Drug Administration (FDA) has approved Narcan (naloxone HCl) Nasal Spray for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Prior to the approval, naloxone was only available as an injection in the form of a syringe or auto-injector. However, first responders and caregivers have used unapproved naloxone kits consisting of an injectable form of naloxone with an atomizer because they felt it was easier to deliver naloxone nasally and without the risk of a contaminated needle stick. Clinical trials have shown that administration of Narcan Nasal Spray into one nostril delivered approximately the same or more levels of the drug as a single dose of an FDA-approved naloxone intramuscular injection within the same time frame.
Narcan Nasal Spray delivers a 4mg dose in a single 0.1mL spray. It contains naloxone, an opioid antagonist, that works by antagonizing opioid effects by competing for the same receptor sites. It reverses the effects of opioids, including respiratory depression, sedation, and hypotension. It can also reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.
Narcan Nasal Spray does not require assembly and the drug is sprayed into one nostril while the patient is lying on his/her back. It is not a substitute for emergency medical care.
Narcan Nasal Spray will be available as a carton containing 2 blister packs each with a single nasal spray. It is expected to launch in early 2016.
For more information call (844) 462-7226 or visit NarcanNasalSpray.com.