Originally published by our sister publication, Pain Medicine News.
Two FDA committees recommended against the approval of a New Drug Application (NDA) for IV tramadol (Avenue Therapeutics) for the treatment of acute pain that is severe enough to require an opioid analgesic in an inpatient setting.
By a 14-8 vote in a joint meeting, the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee decided that the company had not adequately shown