Eli Lilly said May 29 that it submitted a supplemental new drug application in the second quarter for Cymbalta (duloxetine) for the management of chronic pain.

With an expected 10-month review, the drug's likely PDUFA timeframe would be February to March 2009.

The serotonin-norepinephrine reuptake inhibitor is approved for acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder and the management of diabetic peripheral neuropathic pain, all in adults 18 and older.

Cymbalta is under FDA review now for treatment of fibromyalgia with an expected PDUFA date in June (¹ Also see "Cymbalta Fibromyalgia sNDA Could Make Lilly Product Lyrica’s First Competitor" - Pink Sheet, 21 August, 2007.). The clinical trials that supported the fibromyalgia sNDA also support the chronic pain indication.

Lilly also submitted data from three additional clinical trials, two in chronic low back pain and one in osteoarthritis of the knee, the firm said in an interview.

During first-quarter 2008, Cymbalta bypassed Zyprexa as Lilly's top-selling product in the U.S., EVP Global Marketing & Sales Bryce Carmine said at the Deutsche Bank Securities Health Care conference May 5.

Cymbalta posted first-quarter 2008 U.S. sales of $511.1 million, an increase of 32 percent over the previous year's first quarter. Zyprexa sales were $499.3 million (³ Also see "Prasugrel Sales Force Poised For FDA Decision In June, Lilly Says" - Pink Sheet, 21 April, 2008.).

-Pamela Taulbee (p.taulbee@elsevier.com)

Lilly Submits Cymbalta For Chronic Pain

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