Sun Pharmaceutical Industries Ltd. announced that one of its wholly owned subsidiaries has launched Drizalma Sprinkle™ (duloxetine delayed-release capsules) in the U.S. for oral use.
Drizalma Sprinkle is a serotonin and norepinephrine reuptake inhibitor (SNRI) designed for the treatment of various neuro-psychiatric and pain disorders in patients who have difficulty swallowing – a problem that is estimated to affect approximately 30-35% of long-term care residents. The U.S. Food and Drug Administration (FDA) approved Drizalma Sprinkle on July 19, 2019. The availability of Drizalma Sprinkle expands Sun Pharma’s portfolio of alternative formulation products designed for individuals with swallowing difficulties, the risk of which increases with age and exposure to age-related diseases and conditions – including depression, anxiety, and pain disorders.
Drizalma Sprinkle joins Ezallor Sprinkle™ (Rosuvastatin) and Kapspargo Sprinkle™ (metoprolol succinate) extended-release capsules as the third product in Sun Pharma’s US portfolio designed for individuals in long-term care. It is common practice in long-term care facilities to crush medications to ease administration, but crushing tablets introduces additional risks into the administration process. The Joint Commission International Accreditation Standards for Long Term Care urges facilities to dispense medications in forms that require minimal manipulation.
“The launch of Drizalma Sprinkle is an important milestone for people with difficulty swallowing, as this formulation of duloxetine can facilitate treatment of common neuro-psychiatric disorders while preserving the quality of the medicine,”
said Abhay Gandhi, CEO, North America, Sun Pharma.
”This launch further underscores our commitment to providing a portfolio of alternative formulation products to treat common diseases – especially in long-term care, where 30-35% of individuals have difficulty swallowing. These patients often encounter medication errors and challenges with medication administration.”
Drizalma Sprinkle is indicated for the treatment of major depressive disorder (MDD) in adults, generalized anxiety disorder (GAD) in adults and pediatric patients 7-17 years old, diabetic peripheral neuropathic pain (DPNP) in adults, and chronic musculoskeletal pain in adults. It is available in four dosage strengths (20mg, 30mg, 40mg, and 60mg). Drizalma Sprinkle is the first and only FDA-approved formulation of duloxetine that can be swallowed whole, sprinkled on applesauce or administered via nasogastric tube.
Drizalma Sprinkle carries a boxed warning for suicidal thoughts and behaviors. In clinical trials of Drizalma Sprinkle, the most common adverse reactions (in at least 5% of participants and at least twice the incidence of placebo) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis.