Two days after Adapt Pharma announced that it had submitted an NDA for Narcan naloxone nasal spray, Indivior has announced that the FDA has accepted its naloxone nasal spray NDA for priority review. Indivior says that it expects its product to be the first intranasal naloxone approved by the FDA for the treatment of opioid overdose, with a response from the agency expected by the end of 2015.
Indivior, formerly known as Reckitt Benckiser Pharmaceuticals, acquired the pre-filled, unit dose naloxone nasal spray from AntiOp in May 2014. In July 2014, AntiOp announced that it received Fast Track Designation for the product from the FDA .
Indivior Chief Medical Officer Tim Baxter commented, “As the rate of opioid overdoses and their profound impact on communities nationwide continues to rise, naloxone nasal spray may help make every life-saving second count by potentially allowing anyone—be they layperson, trained healthcare personnel or first responders—to administer treatment at the scene of an overdose. We look forward to continuing to work closely with the FDA through the review process to make this vital treatment option widely available.”
Read the Indivior press release.
