An expert panel convened by the U.S. Food and Drug Administration voted not to recommend the approval of INSYS Therapeutics Inc.'s buprenorphine spray to treat moderate to severe acute pain.
The FDA is not required to act on the advice of its advisory panels but generally does so.
INSYS said it will continue to work with the U.S. regulator for its buprenorphine product candidate and to "build on the current body of evidence for its efficacy and safety."
