September 2, 2021

The U.S. FDA has approved a new indication for Drizalma Sprinkle™ (duloxetine) delayed- release oral capsules, manufactured by Sun Pharmaceutical. The capsules are now indicated to treat fibromyalgia in adults.

Fibromyalgia is a pain disorder that may occur when pain is amplified based on how the brain and spinal cord process pain signals. The condition can be a source of disability and leads to widespread pain, fatigue, and difficulty focusing and performing mental tasks. It often occurs alongside other conditions such as migraines, irritable bowel syndrome, restless leg syndrome, sleep apnea, and depression.

In clinical trials, patients diagnosed with fibromyalgia and treated with duloxetine (the active pharmaceutical ingredient in Drizalma Sprinkle) had statistically significantly improvements in mean pain scores from baseline. An increased proportion of patients on duloxetine (compared to those on placebo) had at least at least a 50% reduction in pain score from baseline.

Recommended dosing for fibromyalgia in adults is a starting dose of 30mg taken by mouth once daily for at least one week, followed by a target dose of 60mg once daily. According to the prescribing information, there is no evidence that a higher dose has a clinical benefit, even if a patient does not respond to treatment at 60mg once a day. Higher doses are associated with a higher rate of adverse reactions

Drizalma Sprinkle first received FDA approval in 2019.

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