The Conversation (0)
INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray
May. 23, 2018 08:49AM PST
Pharmaceutical Investing
INSYS Therapeutics (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 …
INSYS Therapeutics (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.
As quoted in the press release:
“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.”
