The FDA has approved a 505(b)(2) NDA for Hikma’s Kloxxado naloxone nasal spray for the reversal of opioid overdose. Hikma says that it expects to launch the nasal spray, which was approved for use in pediatric and adult patients, in the second half of this year.
Kloxxado delivers 8 mg of naloxone per dose, twice as much as the higher dose of Narcan naloxone nasal spray. The FDA approved the 4 mg dose of Narcan in November 2015 and a 2 mg dose in January 2017.
The naloxone nasal spray was initially developed by Insys, which in December 2018 announced plans to file the NDA sometime in 2019. Insys declared bankruptcy in June 2019 and put all of its assets up for sale at that time. In August 2019, Hikma announced that it had acquired the naloxone nasal spray along with an epinephrine nasal spray and unit dose nasal spray manufacturing capabilities.
Center for Drug Evaluation and Research Director Patrizia Cavazzoni said, “Today’s action meets another critical need in combatting opioid overdose. Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most.”
Hikma Generics President Brian Hoffmann commented, “The approval of Kloxxado is an important step in providing patients, friends and family members – as well as the public health community – with an important new option for treating opioid overdose. As an experienced provider of addiction therapy treatments and a leading producer of nasal sprays in the US, we are pleased to leverage our capabilities to deliver an important new tool in the fight against opioid overdose.”
Read the FDA press release.
Read the Hikma press release.
