Saturday, August 21, 2010

Depression is Painful. Advisory Panels more so.

Note: Eli Lilly markets it's anti-depressant Cymbalta saying
"depression is painful," however the research is mixed. The tagline is
mainly founded on the yet unproven assumption by psychiatrists that
pain is all in the mind if it cannot be proven otherwise. Detractors
suggest the hypothesis is all in the mind of psychiatrists.

The article below suggests another reason behind the push for Cymbalta
which was approved for fibromyalgia in 2008. Cymbalta ads are in direct contrast to ads for Lyrica which is prescribed for neuropathological pain in which fibromyalgia patients are portrayed as vibrant people who want to move past the pain and get on with living.

Depression Is Painful. Advisory Panels More So.
By Brian Orelli, Ph.D. |
August 20, 2010 |

Eli Lilly's (NYSE: LLY) date with the Food and Drug Administration
advisory committee was better than nothing. I guess. Certainly can't
make things worse, as was the case for its Alzheimer's drug earlier in
the week.

The committee voted 8-6 in favor of expanding the use of its
depression-turned-pain-drug Cymbalta into patients with chronic pain.
That's not exactly a resounding endorsement.
And it only gets more ambiguous from there. Eli Lilly used studies in
patients that had back pain and those with osteoarthritis to support
the chronic pain indication. The committee voted 8-5 that the data
supported Cymbalta's use in back pain but with a 4-9 vote, found that
the data didn't support its use in osteoarthritis.

This is normally where I'd point out that the FDA usually -- but not
always -- follows the advice of the committee, but with mixed advice,
it seems that the FDA is pretty much on its own here. It's not clear
exactly when the agency might make its decision since the PDUFA date
came and went many months ago.

What is clear is that Eli Lilly could use the additional sales.
Pending appeal, the company is at the losing end of patent fight over
attention-deficit-disorder drug Strattera. If it can't convince a
court otherwise, generic competition from Teva Pharmaceutical (Nasdaq:
TEVA), Mylan (Nasdaq: MYL), Novartis (NYSE: NVS), and Dr. Reddy's
Laboratories (NYSE: RDY) will be on its way shortly.

If the FDA does give Eli Lilly the green light to market Cymbalta for
the expanded indication, they seem to have a tag line all set up. The
advertisements for Cymbalta say that "depression is painful". Flip it
around -- "pain is depressing" -- and you've got one drug that can
treat both.
That's something Pfizer's (NYSE: PFE) Celebrex and Johnson
& Johnson's (NYSE: JNJ) Tylenol can't say. But for now, they're the
ones that can advertise to patients with pain.

Lilly Moves Closer to Approval to Market Cymbalta for Chronic Pain
Published: August 19, 2010

A federal panel on Thursday voted narrowly to recommend allowing Eli
Lilly to market its blockbuster antidepressant Cymbalta for some
chronic pain conditions like lower back ailments that affect millions
of Americans.
Sales of Lilly's antidepressant Cymbalta are $3 billion a year.

The scientific advisory panel to the Food and Drug Administration
voted 8-6 in favor of expanding approved uses of Cymbalta. If approved
by the agency, the drug would compete with Tylenol, aspirin and other
anti-inflammatory drugs, and opioids like codeine and morphine.

F.D.A. officials at the meeting assured the panel they would draft
warnings against the overuse of Cymbalta for pain, if they did finally
approve a label change. Advisory committee votes are often, but not
always, followed by the agency.

"I think it will be a very useful drug for a significant number of
patients," Dr. Jeffrey R. Kirsch, the chairman of the advisory panel,
said after the vote.
But while the committee, in a series of votes, approved the drug's
effectiveness for lower back pain, it voted against the drug's use for
osteoarthritis. The F.D.A. staff earlier in the week opposed Lilly's
broader proposal that would have allowed Cymbalta to be used for
chronic pain on a host of issues.

Dr. Robert Baker, Lilly's global development leader for psychiatry and
pain disorders, said the company would continue seeking F.D.A.
approval to market Cymbalta to treat all chronic pain.
In an interview, he said Lilly learned only this week that the agency
had limited votes to just two conditions. "While we'd have been happy
to move right to chronic pain, we are also understanding and
interested in helping them capture this for doctors as they work for
patients for individual subsets of pain such as osteoarthritis or
lower back pain," Dr. Baker said.

"If you think of how many people have lower back pain, it's an
extraordinarily large opportunity," C. Anthony Butler, a Barclays
analyst, said. The Barclays note predicted Lilly, which is based in
Indianapolis, would invest heavily in promotion because it was relying
on Cymbalta for sales growth from next year, when its patent expires
on its best-selling drug, Zyprexa, to 2013, when its patent expires on

But Lilly also was criticized Thursday by the F.D.A. panel members for
its advertising campaign for Cymbalta. The ads say "depression is
painful." Dr. Kirsch, who is chairman of the department of
anesthesiology at the Oregon Health Sciences University, said he was
perturbed at what he termed an attempt to "premarket" the drug for a
pain use that had not yet been approved.

The F.D.A. approved Cymbalta for major depression and diabetic nerve
pain in 2004, generalized anxiety disorder in 2007, and fibromyalgia
in 2008.
Approval for lower back pain alone could add as much as $500 million
in annual sales of Cymbalta, on top of its $3 billion current sales,
an investor note from Barclays Capital said Thursday.

Full story at:


No comments: