Insys Therapeutics (INSY) Confirms FDA Panel on Buprenorphine Voted Not to Recommend Approval

May 22, 2018 3:09 PM

INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, confirmed today that an expert panel convened by the U.S. Food and Drug Administration (FDA) voted not to recommend approval of the company’s New Drug Application (NDA) for a buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain.

“We appreciate the panelists’ perspective and guidance,” said Steve Sherman, senior vice president of regulatory affairs for INSYS Therapeutics. “Believing that our sublingual delivery technology could contribute significantly to bring value to patients, 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.”

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