Duloxetine (120mg/day)b
 25.1 (7.24)
 -12.5 (0.67)
 -4.1 (-5.9, -2.3)
 

 Placebo
 25.8 (7.66)
 -8.4 (0.67)
 --
 
Study 2
(HAM-A)
 Duloxetine
(60 to 120mg/day)b
 22.5 (7.44)
 -8.1 (0.70)
 -2.2 (-4.2, -0.3)
 

 Placebo
 23.5 (7.91)
 -5.9 (0.70)
 --
 
Study 3
(HAM-A)
 Duloxetine
(60 to 120mg/day)b
 25.8 (5.66)
 -11.8 (0.69)
 -2.6 (-4.5, -0.7)
 

 Placebo
 25.0 (5.82)
 -9.2 (0.67)
 --

Figure 2: Kaplan-Meier Estimation of Cumulative Proportion of Patients with Relapse (GAD Study 4)

Figure 2

Pediatric use information for patients ages 7 to 17 years is approved for Eli Lilly and Company, Inc.'s CYMBALTA® (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

14.3 Diabetic Peripheral Neuropathic Pain
 
The efficacy of duloxetine for the management of neuropathic pain associated with diabetic peripheral neuropathy was established in 2 randomized, 12-week, double-blind, placebo-controlled, fixed-dose studies in adult patients having diabetic peripheral neuropathic pain for at least 6 months. Study DPNP-1 and Study DPNP-2 enrolled a total of 791 patients of whom 592 (75%) completed the studies. Patients enrolled had Type I or II diabetes mellitus with a diagnosis of painful distal symmetrical sensorimotor polyneuropathy for at least 6 months. The patients had a baseline pain score of ≥4 on an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Patients were permitted up to 4 g of acetaminophen per day as needed for pain, in addition to duloxetine. Patients recorded their pain daily in a diary.

Both studies compared duloxetine 60 mg once daily or 60 mg twice daily with placebo. DPNP-1 additionally compared duloxetine 20 mg with placebo. A total of 457 patients (342 duloxetine, 115 placebo) were enrolled in DPNP-1 and a total of 334 patients (226 duloxetine, 108 placebo) were enrolled in DPNP-2. Treatment with duloxetine 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. For various degrees of improvement in pain from baseline to study endpoint,  Figures 3 and 4 show the fraction of patients achieving that degree of improvement. The figures are cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. 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.

Figure 3

Figure 4

14.5 Chronic Musculoskeletal Pain
 
Duloxetine is indicated for the management of chronic musculoskeletal pain. This has been established in stu