Cymbalta Receives FDA Panel Approval for Low Back Pain

Physicians may soon be able to add Cymbalta to their arsenal in treating some chronic pain conditions, thanks to an FDA advisory panel vote to allow drug maker Eli Lilly to market the antidepressant as a treatment for low back pain.

The vote was 8-to-6 in favor and expands the use of Cymbalta, as reported by the New York Times.

The drug was approved by the panel for use in treating lower back pain, but was not approved for osteoarthritis, which was the second condition for which the drug makers sought approval.

The article reports that “Analysts have estimated that pain sales could add up to $500 million a year to the $3 billion in Strattera sold last year. But the mixed comments from the F.D.A. panel and staff scientists seemed to assure it would have a more limited effect.”

The next step, as dictated by FDA officials at the meeting is to “craft cautions against overuse of Cymbalta for pain if they do finally approve a label change,” the article writes. The drug now must seek approval by a vote from the agency to officially expand the label use.