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Depression Is Painful. Advisory Panels More So.

By Brian Orelli, PhD – Updated Apr 6, 2017 at 12:03PM

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Eli Lilly's Cymbalta has a rough time in from of the panel of experts.

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.

Jim Royal doesn't see any pain in today's 11 o'clock recommendation.

Pfizer is a Motley Fool Inside Value pick. Novartis and Dr. Reddy's Laboratories are Global Gains recommendations. Johnson & Johnson is an Income Investor pick and Motley Fool Options has recommended a diagonal call position on its stock. Try any of our Foolish newsletter services free for 30 days.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.

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Stocks Mentioned

Eli Lilly and Company Stock Quote
Eli Lilly and Company
LLY
$311.46 (0.19%) $0.59
Pfizer Inc. Stock Quote
Pfizer Inc.
PFE
$44.08 (-1.10%) $0.49
Novartis AG Stock Quote
Novartis AG
NVS
$76.01 (-1.47%) $-1.13
Teva Pharmaceutical Industries Limited Stock Quote
Teva Pharmaceutical Industries Limited
TEVA
$7.90 (-1.98%) $0.16
Viatris Inc. Stock Quote
Viatris Inc.
MYL
Johnson & Johnson Stock Quote
Johnson & Johnson
JNJ
$166.72 (0.33%) $0.54
Dr. Reddy's Laboratories Limited Stock Quote
Dr. Reddy's Laboratories Limited
RDY
$50.65 (-1.31%) $0.67

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

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