Insys Therapeutics, which recently filed for bankruptcy, said that the FDA has accepted its NDA for the company’s single unit dose naloxone nasal spray. In December 2018, Insys said that it planned to submit NDAs for both the naloxone nasal spray and an epinephrine nasal spray in 2019.
Insys Chief Scientific Officer Venkat Goskonda said, “The FDA’s acceptance of the NDA for Insys’ proprietary formulation of a naloxone nasal spray is an important milestone in battling the US opioid epidemic. We believe our formulation has the potential to be a critical tool in combatting opioid overdose cases. The rapid absorption and significant exposure of the formulation may be useful in opioid overdose, particularly with the rise of synthetic opioid use.”
Read the Insys Therapeutics press release.
