FDA panel votes not to recommend approval for INSYS Therapeutics' buprenorphine sublingual spray

INSYS Therapeutics announced Tuesday that an FDA advisory panel voted against recommending the company's marketing application for a buprenorphine sublingual spray to treat moderate-to-severe acute pain. Steve Sherman, senior vice president of regulatory affairs for INSYS, said "we will continue to work with the FDA in the coming months to discuss the path forward for our buprenorphine product candidate and to build on the current body of evidence for its efficacy and safety." 

INSYS initially filed sublingual buprenorphine spray for review last September. Data from a Phase III placebo-controlled study unveiled in 2016 showed that the therapy had met the primary endpoint of summed pain intensity difference relative to baseline over a 48-hour period at all tested doses in patients with moderate-to-severe postoperative pain after bunionectomy. 

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Earlier this month, the US Department of Justice joined a whistleblower lawsuit accusing INSYS of offering kickbacks to doctors to prescribe Subsys (fentanyl). Last year, a number of executives including founder John Kapoor were charged by the Justice Department of illegally promoting products, with Kapoor later pleading not guilty to the allegations. 

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