INSYS Receives NDA Approval for Novel Pain Management Treatment

INSYS Therapeutics (NASDAQ:INSY) announced its New Drug Application (NDA) for the formulation of buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain was approved by the US Food and Drug Administration (FDA).
As quoted in the press release:

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of July 28, 2018 to complete its review of this NDA, 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.

“We look forward to working with the FDA in 2018 to add our buprenorphine sublingual spray to the range of treatment options available to physicians whose patients suffer from moderate-to-severe acute pain,” said Steve Sherman, senior vice president of regulatory affairs at INSYS. “We believe that this novel formulation and delivery method of buprenorphine holds great promise as an alternative to traditional opioids.”

Click here to read the full press release.

Source: globenewswire.com