UPDATE 2-FDA staff question wider use of Lilly’s Cymbalta

* Drugmaker seeks U.S. approval to sell Cymbalta for pain

* FDA to ask outside advisers about safety with wider use

* FDA’s advisers to weigh possible new use Thursday

* Shares down 2.5 pct after another Lilly drug halted
(Adds details from documents, share price, analyst comment)

By Susan Heavey

WASHINGTON, Aug 17 (BestGrowthStock) – U.S. government scientists
raised safety concerns about using Eli Lilly and Co’s (LLY.N: )
blockbuster antidepressant Cymbalta to treat pain, also noting
that approval of the new use would likely cause “a substantial
increase” in prescriptions among the wider population.

Food and Drug Administration staff, in documents released
on the agency’s website on Tuesday, said they would ask a panel
of outside advisers about the potential for liver toxicity and
whether broadening use of the drug would be appropriate.

The FDA released the documents ahead of a public meeting on
Thursday to discuss the potential new use of the drug to treat
conditions such as low back pain and osteoarthritis.

Shares of Eli Lilly were down 2.5 percent to $34.68 in
afternoon trading on the New York Stock Exchange. Earlier on
Tuesday the company said it had halted development of an
experimental Alzheimer’s disease treatment. [ID:nN17120793]

Cymbalta is already approved for depression, anxiety,
diabetes-related pain and fibromyalgia, but Eli Lilly also wants permission to market it for chronic pain.

More than 50 million Americans experience chronic pain,
according to the company. Treating such patients could help
boost sales before Cymbalta loses its U.S. patent exclusivity
in mid-2013.

Analysts expect the antidepressant to garner worldwide
sales of $3.4 billion in 2010 and $3.7 billion in 2011,
according to consensus forecast data from Thomson Reuters. It
was unclear if the figures include approval of Cymbalta for
chronic pain.

At the Thursday meeting, an FDA panel of outside experts
will decide whether to back wider use of the drug. It was
unclear how the FDA staff’s review would affect the advisory
panel’s recommendation. The FDA will make the final decision,
but it usually follows panel recommendations.

In nearly 200 pages of analysis, FDA staff said no new side
effects cropped up in Lilly’s pain studies and that the drug’s
risks were already pretty well characterized on its label.

Known side effects with Cymbalta, also know as duloxetine
and first approved in 2004, include dizziness, nausea and
drowsiness. Like other antidepressants, the drug already
carries a strong “black box” warning about possible suicidal
tendencies in children, teenagers and young adults.

At issue is how those risks might increase given
potentially millions more users.

“Keep in mind that the approval of Cymbalta for the
treatment of chronic pain will likely result in a substantial
increase in the prescribing of the product in the general
population,” Bob Rappaport, head of the FDA division that
oversees pain-related drugs, advised panelists in a memo.

Separately, Eli Lilly said current painkillers such as
opioids and nonsteroidal anti-inflammatory drugs also carry
risks, and that the company has a substantial risk-monitoring
program already in place to help monitor Cymbalta’s safety.

FDA staff also said Eli Lilly’s clinical trials were well
designed with an adequate mix and number of patients. But
reviewers evaluating efficacy data identified “several key
points” as “problematic,” the FDA wrote in its review.

The drugmaker withdrew its earlier bid for pain use in
November 2008 to add more data. It is unclear when the FDA may
act as the new deadline for the agency’s decision has already
passed, Lilly’s spokeswoman, Sonja Kay Popp-Stahly, said.
(Reporting by Susan Heavey; additional reporting by Ransdell
Pierson in New York; editing by John Wallace)

UPDATE 2-FDA staff question wider use of Lilly’s Cymbalta