Sun Pharma launches Drizalma Sprinkle in US for treating neuro-psychiatric and pain disorders in patients with swallowing difficulties

New Delhi: Sun Pharmaceutical Industries recently 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 company's portfolio of alternative formulation products designed for individuals with swallowing difficulties, the company said.

"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," Sun Pharma North America CEO Abhay Gandhi said.

"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,” he added

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Drizalma sprinkle is 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 per of long-term care residents, the company said.

It is the first and only FDA approved formulation of duloxetine that can be swallowed whole, sprinkled on apple sauce or administered via nasogastric tube, it added. Shares of Sun Pharmaceutical Industries were trading at Rs 397.70 on BSE, up 0.33 per cent from the previous close.

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.

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