Lilly's Cymbalta helps chronic pain in U.S. review

Back to TopCommentsE-mailPrintBookmark and Share

Eli Lilly and Co.’s antidepressant Cymbalta helped people with chronic pain and wasn’t linked to new side effects, according to U.S. regulators weighing whether to expand use of the drugmaker’s second-biggest product.

Cymbalta doses of 60 milligrams to 120 milligrams reduced pain more than placebos in studies of people with osteoarthritis of the knee or lower back pain, Food and Drug Administration staff said in a report released Tuesday. Outside advisers to the agency were asked to weigh these benefits against the known risk of liver toxicity at an Aug. 19 meeting in Bethesda, Md.

Approval for the millions of Americans with chronic back or knee pain may add more than $500 million, or 16 percent, to Cymbalta’s annual sales, according to Seamus Fernandez, an analyst at Leerink Swann & Co. in Boston who rates Lilly shares “underperform.” Lilly’s application already has been met with several delays, raising doubts that it will be successful.

“Cymbalta has the potential to be a very versatile drug,” said Ira Loss, an analyst at Washington Analysis who has followed the FDA for more than three decades, in an Aug. 3 phone interview. “My guess is that FDA is skeptical. Safety is an issue.”

Shares in Lilly, based in Indianapolis, fell 82 cents, or 2.3 percent, to $34.75 in early trading before the New York Stock Exchange opened. The drugmaker said earlier Tuesday that it will halt development of an experimental treatment for Alzheimer’s disease because the medicine, semagacestat, was associated with worsening cognition and an increased risk of skin cancer.

Cymbalta was cleared by the FDA in 2004 for adults with major depression. Approval was extended to treating nerve pain in diabetics, generalized anxiety disorder and fibromyalgia, a condition characterized by chronic fatigue and muscle and joint pain. While Cymbalta isn’t approved for kids, it carries the same boxed warning as other antidepressants about the risk of suicidal thoughts and behavior in children and young adults.

Sales of Cymbalta were $3.07 billion last year, accounting for 14 percent of Lilly’s revenue. The drug is scheduled to lose U.S. patent protection in 2013. Lilly's top-selling Zyprexa, an antipsychotic, faces generic competition in 2011.

“The overarching issue with Lilly is the collection of expiring patents,” said Tony Butler, an analyst at Barclays Capital in New York, in an Aug. 4 telephone interview. “Cymbalta unfortunately expires in 2013. It’s not like we’re going to get a lot” of mileage out of a new approval.

Lilly asked for approval in chronic pain in the second quarter of 2008 before withdrawing the application after the FDA raised concerns about study design and statistical methodology. The application was resubmitted in June 2009. An advisory panel review initially slated for January was canceled so regulators could have more time to consider new information pertaining to the drug’s “benefit-risk balance” in treating pain.

An estimated 10 million Americans have osteoarthritis of the knee, according to Lilly. In a study of 256 people with the disorder reported in January 2009, Cymbalta helped 65 percent of patients feel better, compared with 44 percent who felt better on placebo. Another measure of pain and stiffness didn’t show a statistically significant benefit for Cymbalta.

Once-daily Cymbalta helped reduce the severity of chronic low back pain in a 401-person study reported in February. Thirty people in the Cymbalta group withdrew from treatment because of side effects such as nausea, headache, dry mouth, constipation and dizziness, compared with 11 people in the placebo group. A separate study reported in September found that reduction in lower back pain was maintained after 41 weeks.

It’s unusual for the FDA to grant broad approval for “chronic pain” instead of a more specific condition, said Kurt Kroenke, a professor of medicine at Indiana University’s School of Medicine in Indianapolis who has consulted for Lilly.

Many painkillers are sold cheaply as generics. Patients usually first try acetaminophen and ibuprofen, which are widely available over the counter. Older antidepressants known as tricyclics are also recommended in clinical guidelines, though they aren’t approved for chronic pain. Doctors try to limit use of oxycodone, hydrocodone and other opiate narcotics because they can be misused or lead to addiction, Kroenke said.

“A number of patients with more moderate or severe pain probably need medicines from other classes,” Kroenke said in an Aug. 9 telephone interview. “If we had options before we had to move on to opiates, that would be beneficial.”


Post a comment to this story

We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
You are legally responsible for what you post and your anonymity is not guaranteed.
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
Subscribe to IBJ
  1. The deductible is entirely paid by the POWER account. No one ever has to contribute more than $25/month into the POWER account and it is often less. The only cost not paid out of the POWER account is the ER copay ($8-25) for non-emergent use of the ER. And under HIP 2.0, if a member calls the toll-free, 24 hour nurse line, and the nurse tells them to go to the ER, the copay is waived. It's also waived if the member is admitted to the hospital. Honestly, although it is certainly not "free" - I think Indiana has created a decent plan for the currently uninsured. Also consider that if a member obtains preventive care, she can lower her monthly contribution for the next year. Non-profits may pay up to 75% of the contribution on behalf of the member, and the member's employer may pay up to 50% of the contribution.

  2. I wonder if the governor could multi-task and talk to CMS about helping Indiana get our state based exchange going so Hoosiers don't lose subsidy if the court decision holds. One option I've seen is for states to contract with healthcare.gov. Or maybe Indiana isn't really interested in healthcare insurance coverage for Hoosiers.

  3. So, how much did either of YOU contribute? HGH Thank you Mr. Ozdemir for your investments in this city and your contribution to the arts.

  4. So heres brilliant planning for you...build a $30 M sports complex with tax dollars, yet send all the hotel tax revenue to Carmel and Fishers. Westfield will unlikely never see a payback but the hotel "centers" of Carmel and Fishers will get rich. Lousy strategy Andy Cook!

  5. AlanB, this is how it works...A corporate welfare queen makes a tiny contribution to the arts and gets tons of positive media from outlets like the IBJ. In turn, they are more easily to get their 10s of millions of dollars of corporate welfare (ironically from the same people who are against welfare for humans).