Eli Lilly and Co. said on Tuesday that U.S. regulators have approved its new antidepressant as a treatment for pain associated with nerve damage in diabetics, making it the first drug approved for the disorder and sending the company’s shares up 2 percent.
The Food and Drug Administration said Lilly can market the drug Cymbalta to treat diabetic peripheral neuropathic pain, which affects up to 5 million Americans. Last month the FDA approved Cymbalta as a treatment for major depression. Analysts said the approval for the additional indication came sooner than expected and would significantly add to Cymbalta’s revenue potential. “Just for this indication we see sales of over $1 billion,” said Albert Rauch, an analyst for A.G. Edwards & Sons. “Along with depression, Cymbalta could reach $3 billion to $5 billion annual peak sales.” The new approval is based on the results of two 12-week studies — each clinical trial tested a different dosage — in non-depressed adults. On average, patients in the studies were 60 years old, had suffered from diabetes for 11 years and from related nerve pain for four years. The company said Cymbalta significantly reduced 24-hour average pain levels compared with a placebo. While the drug does not treat the nerve damage that causes the pain, it reduces the symptoms of stabbing, burning and shooting pain associated with the disorder. In the trials, 58 percent of patients treated with Cymbalta reported at least a 30 percent sustained reduction in pain. That compared with 34 percent of patients receiving a placebo who reported a similar sustained pain reduction. Cymbalta raises levels of two chemicals in the brain: serotonin and norepinephrine. Many scientists believe the raised level of norepinephrine is mainly responsible for the effect on pain. Rauch said the additional approval would allow Cymbalta to more effectively compete with Wyeth’s antidepressant Effexor, which works in a similar fashion. It also gives Lilly a leg up on Pfizer Inc.’s pregabalin, which must still meet certain conditions before the FDA will approve the drug for neuropathic pain in diabetics. “This puts Lilly in a good marketing position against Effexor and against pregabalin,” Rauch said. Shares of Eli Lilly were up $1.49, or 2.3 percent, to $66.47 in afternoon trading on the New York Stock Exchange. (Source: Reuters Health News: Toni Clarke and Bill Berkrot: September 2004.)