Lilly will begin promoting Cymbalta for diabetes-related neuropathic pain in the fourth quarter, the company said.

Sales reps will position the serotonin-norepinephrine reuptake inhibitor as an antidepressant before starting promotion of the neuropathic pain indication in the fourth quarter.

Cymbalta (duloxetine) cleared FDA Sept. 3 for management of neuropathic pain associated with diabetic peripheral neuropathy.

The product was approved with an initial indication in major depressive disorder Aug. 3 (¹ Also see "Cymbalta Approved; Lilly Antidepressant Will Be Available By Late August" - Pink Sheet, 4 August, 2004.).

Cymbalta "is the first drug specifically approved for this indication," an ² FDA Talk Paper announcing the neuropathic pain approval said. The indication received a six-month priority review, Lilly said.

During the launch phase, the primary marketing objective is to position Cymbalta as a first-line antidepressant with psychiatrists and primary care physicians, Lilly said.

Cymbalta launch was set for late August so that Lilly could build sufficient inventory.

For the neuropathic pain indication, Cymbalta sales reps will visit neurologists and pain specialists beginning in the fourth quarter, Lilly said.

After the company is confident Cymbalta is appropriately positioned as an antidepressant, Lilly will begin more active promotion of the neuropathic pain indication to primary care physicians, the company stated.

Cymbalta efficacy in the treatment of diabetes-related neuropathic pain was demonstrated in two randomized placebo controlled trials, each lasting 12 weeks, comparing a dose of 60 mg or 120 mg once-daily with placebo, ³ labeling says.

The studies enrolled 791 patients with Type I or II diabetes mellitus with a diagnosis of painful distal symmetrical sensorimotor polyneuropathy for at least six months; 592 patients completed the trials.

"Treatment with Cymbalta 60 mg one or two times a day statistically significantly improved the endpoint mean pain scores from baseline and increased the proportion of patients with at least a 50% reduction in pain scores from baseline," labeling says. "Patients who did not complete the study were assigned 0% improvement."

"Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study," labeling adds.

Labeling suggests administering a dose of 60 mg daily for the diabetic peripheral neuropathic pain indication.

"While a 120 mg/day dose was shown to be safe and effective, there is no evidence that doses higher than 60 mg confer additional significant benefit, and the higher dose is clearly less well tolerated," labeling states.

Side effects most commonly reported were nausea, somnolence, dizziness, constipation, dry mouth, hyperhidrosis, decreased appetite, and asthenia.

Cymbalta is supplied in three strengths: 20 mg, 30 mg, and 60 mg. Major depressive disorder should be dosed between 40 mg per day to 60 mg per day, labeling says.

The average wholesale price for a 60 mg capsule of Cymbalta is $3.56 (⁴ Also see "Lilly Cymbalta Price Is Slight Discount To Highest Dose Of Effexor XR" - Pink Sheet, 9 August, 2004.).

Lilly is pursuing a third application for duloxetine for stress urinary incontinence. For that indication, Lilly expects to use a different brand name, Yentreve . FDA issued an "approvable" letter in August 2003 requesting additional studies for the indication.

Yentreve was granted marketing authorization for the European Union Aug. 13 (⁵ Also see "Duloxetine Approved In EU For Stress Urinary Incontinence" - Pink Sheet, 13 August, 2004.).

- Adam Eckstein

Lilly Cymbalta Clears FDA For Diabetes-Related Neuropathic Pain After Priority Review

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