Cymbalta, newly approved by the U.S. Food and Drug Administration to treat major depression, has been granted an additional FDA nod to combat diabetic peripheral neuropathic pain (DPNP) caused by nerve damage in the hands and feet.
As many as 5 million American diabetics have DPNP, which can cause intense pain, according to the drug’s maker, Eli Lilly & Co. The FDA granted Cymbalta (duloxetine HCl) six-month priority review, the company said in a statement, noting that more than 18 million Americans have diabetes and are at risk of developing persistent pain.
Cymbalta targets two chemical messengers in the body, serotonin and norepinephrine, believed to play a role in both pain perception and depression, Lilly said. Approval for DPNP came after the FDA reviewed results from two 12-week trials among non-depressed adults. In both trials, improvements were noted as early as the first week of treatment, the company said.
The FDA granted its initial approval for Cymbalta as an antidepressant on Aug. 3.
Revision date: July 5, 2011
Last revised: by Jorge P. Ribeiro, MD