April 22, 2020

The U.S. FDA has approved an extended indication for Cymbalta® (duloxetine) delayed-release oral capsules, manufactured by Eli Lilly. The product is now indicated to treat fibromyalgia in pediatric patients who are at least 13 years of age. Previously, it was approved to treat fibromyalgia in adults only.

Fibromyalgia is a pain disorder in which patients experience widespread musculoskeletal pain in addition to fatigue and issues with memory, sleep, and mood. The disease is not fully understood but may be the result of problems with the way the brain processes pain signals. This may cause the brain to amplify pain sensation beyond what is typical. There is no cure, but treatment can help control and alleviate symptoms.

In a clinical trial, significantly more patients demonstrated a treatment response, defined as a 30% or greater reduction in average pain severity, with Cymbalta compared to patients who received a placebo. Recommended dosing for pediatric patients under the expanded indication is 30mg taken by mouth once daily. If needed and tolerated, dosage can be increased to a maximum of 60mg per day. A black box warning cautions that taking Cymbalta may lead to an increased risk of suicidal ideation and behavior in children, adolescents, and young adults. Patients should be monitored for worsening and emergence of suicidal ideation or behavior.

Cymbalta first received FDA approval in 2004, and is also indicated to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and chronic musculoskeletal pain.

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