October 16, 2019
Sun Pharmaceuticals has announced the launch of Drizalma Sprinkle™ (duloxetine delayed-release capsules) for oral use. FDA approved in July 2019, Drizalma Sprinkle is indicated to treat adults who have major depressive disorder (MDD), diabetic peripheral neuropathic pain (DPNP), or chronic musculoskeletal pain. It is also indicated to treat generalized anxiety disorder (GAD) in adults and in children who are at least seven years of age.
Drizalma Sprinkle is intended specifically to treat patients who may have difficulty swallowing oral medications. An estimated 30-35% of individuals in long-term care facilities experience this difficulty. The product can be taken with or without food, and can be swallowed whole, opened and sprinkled over applesauce, or administered via nasogastric tube.
Recommended dosing varies based on individual patient factors including the patient’s age and diagnosis. For DPNP and chronic musculoskeletal pain, the maximum recommended dose is 60mg/day. For MDD and GAD, dosing should not exceed 120mg/day. However, the prescribing information notes that there is no evidence that doses greater than 60mg/day confer additional benefit, and some adverse reactions were observed to be dose dependent. If treatment with the drug is to be discontinued, the dosage should be reduced gradually to avoid discontinuation symptoms.
A black box warning cautions that antidepressants can increase the risk of suicidal ideation and behavior in pediatric and young adult patients, and that all antidepressant-treated patients should be monitored for clinical worsening and emergence of suicidal ideation and behaviors.
The wholesale acquisition cost (WAC) for Drizalma Sprinkle is $175.50 per month at a dose of 60mg/day.