BRIEF—Avenue blocked in bid for IV tramadol

Shares in Avenue Therapeutics fell by a third on Monday, after the company received a second Complete Response Letter (CRL) from US regulator, regarding its submission for IV tramadol.

The agency said the delayed and unpredictable onset of analgesia with IV tramadol stood in the way of its use as monotherapy for acute pain.

The FDA also said there was “insufficient information” to show that IV tramadol in combination with other analgesics is safe and effective for the intended patient population.

Avenue, part of Fortress Biotech, has been testing the therapy in people with moderate to moderately severe postoperative pain following bunionectomy surgery.

The company said it disagreed with the FDA's interpretation, and that it would continue to pursue regulatory approval.