The Food and Drug Administration (FDA) has expanded the approval of Cymbalta (duloxetine; Lilly) to include treatment of fibromyalgia in pediatric patients 13 to 17 years of age.
The approval was based on data from a 13-week placebo-controlled trial that included 184 patients with juvenile primary fibromyalgia syndrome. Patients were randomized to receive duloxetine 30mg once daily for 1 week, then 60mg once daily for 12 weeks (based on response and tolerability) or placebo. The primary end point of the study was reduction from baseline in average pain severity as measured by the Brief Pain Inventory (BPI)-Modified Short Form: Adolescent Version 24-hour average pain severity rating scale; at baseline, patients had a BPI of 5.7.
Results showed that treatment with duloxetine was not associated with a statistically significant improvement over placebo for the primary end point (mean change: -1.62 vs -0.97, respectively; P =.052), however, significantly more patients had a treatment response (secondary end points defined as ≥30% and ≥50% reductions on BPI average pain severity) with duloxetine than with placebo. The mean duloxetine dosage for patients who completed the 12-week treatment phase was 49mg/day.
As for safety, a greater proportion of duloxetine-treated patients reported at least 1 adverse event related to treatment compared with those who received placebo (82.4% vs 62.4%, respectively; P =.003). Overall, the safety profile was found to be similar to that observed in previous clinical trials of duloxetine.
Cymbalta is available in 20mg, 30mg, and 60mg delayed-release capsules. The capsules should not be opened and the contents should not be sprinkled on food or into liquids as these actions may affect the enteric coating.
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