FDA Accepts New Drug Application for Novel Buprenorphine Sublingual Spray
The Food and Drug Administration has accepted for filing the New Drug Application for its novel buprenorphine sublingual spray for the management of moderate-to-severe acute pain.
Insys Therapeutics announced that the Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its novel buprenorphine sublingual spray for the management of moderate-to-severe acute pain.
The NDA submission was supported by data from a study that met its primary efficacy endpoint in addition to several pharmacokinetic studies. Recently, the Company finished a 7-day safety and tolerability study among 100 patients for which the data will be submitted to the FDA in early 2018.
Compared to other commonly used opioids, buprenorphine offers a ceiling effect for respiratory depression and less abuse potential, less cognitive impairment, and less constipation.
Steve Sherman, SVP of regulatory affairs at INSYS said, “We believe that this novel formulation and delivery method of buprenorphine holds great promise as an alternative to traditional opioids.” The Prescription Drug User Fee Act (PDUFA) target date has been set for July 28, 2018 for completed NDA review.
FDA accepts New Drug Application (NDA) for buprenorphine sublingual spray from INSYS therapeutics [press release]. Phoenix; Globe Newswire: December 6, 2017. Accessed December 8, 2017.