Lilly's antidepressant Cymbalta (duloxetine) is approved for treatment of generalized anxiety disorder, the company announced Feb. 26, following FDA notification on Feb. 23.

Cymbalta will face direct competition from Wyeth's Effexor XR (venlafaxine), another serotonin-norepinephrine reuptake inhibitor approved for GAD. The product also carries indications for major depressive disorder, social anxiety disorder and panic disorder.

Cymbalta is indicated for diabetes-related neuropathic pain and MDD (¹ Also see "Lilly Cymbalta Clears FDA For Diabetes-Related Neuropathic Pain After Priority Review" - Pink Sheet, 7 September, 2004.).

Lilly is "still evaluating the marketing mix" for Cymbalta and hasn't decided whether it will use direct-to-consumer advertising for the new claim, the company told "The Pink Sheet" DAILY. The company's "depression hurts" campaign targets the MDD indication.

The GAD submission was supported by three randomized, double-blind, placebo-controlled studies. On average, as measured by the Hamilton Anxiety Scale, patients experienced a 46 percent improvement in anxiety symptoms compared with 32 percent who took the placebo. In addition, patients reported a 46 percent greater improvement in functional impairment with Cymbalta compared with 26 percent improvement on placebo, measured by the Sheehan Disability Scale.

During the JP Morgan Healthcare conference in January, Lilly Chief Executive Officer John Lechleiter said the firm plans to file a Cymbalta sNDA for treatment of fibromyalgia later in 2007.

AstraZeneca has said it plans to submit a GAD sNDA for its serotonin receptor antagonist Seroquel SR (quetiapine) sometime this year (² Also see "AstraZeneca’s Seroquel Gets FDA Nod For Bipolar Depression" - Pink Sheet, 23 October, 2006.).

- Shirley Haley (s.haley@elsevier.com)

Lilly’s Cymbalta Gets Generalized Anxiety Disorder Indication

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