Insys Therapeutics NDA for Sublingual Spray Pain Drug

FDA has accepted for review an Insys Therapeutics NDA for what it calls a novel formulation of buprenorphine as a sublingual spray for managing moderate-to-severe acute pain. The agency has set a user fee review target date of 7/28/2018. The submission is based primarily on a pivotal trial that met its primary efficacy endpoint and several pharmacokinetics studies.

To expand the drug’s duration of exposure, Insys says it recently completed a seven-day safety and tolerability study with 100 patients. Data from this study will be submitted in the first quarter of 2018, which may impact the user fee date.

The company says it anticipates that the potential benefits of buprenorphine include a “ceiling effect for respiratory depression and, compared to other opioids frequently used in this indication, less abuse potential, less cognitive impairment and less constipation.”