Posted by Michael Wonder on 06 Dec 2017
FDA accepts new drug application for buprenorphine sublingual spray from INSYS Therapeutics
6 December 2017 - Novel formulation of partial opioid offers potential benefits compared to current alternatives.
Insys Therapeutics announced today that its new drug application for a novel formulation of buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain has been accepted for filing by the U.S. FDA.
Under the Prescription Drug User Fee Act, the FDA has set a target date of 28 July 2018 to complete its review of this application, which was based primarily on a pivotal trial that met its primary efficacy endpoint and several pharmacokinetics studies.
To expand the duration of exposure for this investigation new drug candidate, INSYS also recently completed a seven-day safety and tolerability study with 100 patients. Data from this study will be submitted to the FDA in the first quarter of 2018, augmenting the NDA package, and may impact the PDUFA date.
