Sun Pharma Announces Drizalma Sprinkle™ (duloxetine delayed-release capsules) is Now Covered by Most Medicare Part D Plans

2021-03-09

PRINCETON, N.J., March 9, 2021 /PRNewswire/ -- Sun Pharmaceutical Industries, Inc. (Sun Pharma), a wholly owned subsidiary of Mumbai-based Sun Pharmaceutical Industries Limited, today announced that the top 10 Medicare Part D plans, which include 91% of eligible U.S. lives, now cover Drizalma Sprinkle™. Drizalma Sprinkle™ is one of three sprinkle formulation products in Sun Pharma's long-term care (LTC) portfolio, which are prescribed inside and outside of LTC facilities for the 40% of American adults who cannot or will not swallow solid medication forms. Drizalma Sprinkle™ is the first and only U.S. Food and Drug Administration (FDA) approved sprinkle formulation of delayed-release duloxetine capsules and is indicated to treat major depressive disorder (MDD), generalized anxiety disorder (GAD) in adults and pediatric patients aged 7-17, diabetic peripheral neuropathy pain (DPNP), and chronic musculoskeletal pain in adults. Sun Pharma's LTC portfolio also includes the first and only extended-release sprinkle formulations of metoprolol succinate and rosuvastatin. "We are pleased to have extended access for Drizalma Sprinkle™, a unique formulation of duloxetine, for nearly all Medicare Part D recipients especially given the broad need for sprinkle formulations of frequently used medications," said Mark Hagler, Senior Vice President and Head of Ophthalmics, Oncology and LTC at Sun Pharma. "Sun Pharma's sprinkle portfolio changes the experience of taking medication for people who cannot or will not swallow solid medication forms. Often times facilities opt to crush medicines for these patients as a work-around. This practice can lead to medication errors which are federally regulated in LTC facilities. Sprinkle formulations offer the benefit of mitigating this risk while ensuring patients are getting their treatments as prescribed." 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. See more information about Drizalma Sprinkle™ at , and about the Sun Pharma portfolio of LTC products, at . INDICATIONS AND USAGE Drizalma Sprinkle™ (duloxetine delayed-release capsules) for oral use is indicated for the treatment of major depressive disorder in adults; generalized anxiety disorder in adults and pediatric patients aged 7 to 17 years; diabetic peripheral neuropathy in adults, and chronic musculoskeletal pain in adults. IMPORTANT SAFETY INFORMATION WARNING: SUICIDAL THOUGHTS AND BEHAVIORS: Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors. Contraindications Serotonin syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with Drizalma Sprinkle™ or within 5 days of stopping treatment with Drizalma Sprinkle™. Do not use Drizalma Sprinkle™ within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Drizalma Sprinkle™ in a patient who is being treated with linezolid or intravenous methylene blue. WARNINGS AND PRECAUTIONS Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with duloxetine delayed-release capsules. Duloxetine delayed-release capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Drizalma Sprinkle™ should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. Orthostatic Hypotension, Falls, and Syncope: Cases have been reported with duloxetine delayed-release capsules therapy. Syncope and orthostatic hypotension tend to occur within the first week of therapy but can occur at any time during treatment, particularly after dose increases. Serotonin Syndrome: There is increased risk when coadministered with other serotonergic agents (eg, SSRIs, SNRIs, triptans), but also when taken alone. The concomitant use of Drizalma Sprinkle™ with MAOIs is contraindicated. Do not initiate Drizalma Sprinkle™ in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. Monitor all patients taking Drizalma Sprinkle™ for the emergence of serotonin syndrome. If it occurs, discontinue Drizalma Sprinkle™ and initiate supportive treatment. Increased Risk of Bleeding: Duloxetine may increase the risk of bleeding events. Concomitant use of NSAIDs, aspirin, other antiplatelet drugs, warfarin, and anticoagulants may increase this risk. Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome, can occur with duloxetine. Drizalma Sprinkle™ should be discontinued at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified. Discontinuation Syndrome: Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. Activation of Mania or Hypomania: In patients with bipolar disorder, treating a depressive episode with duloxetine delayed-release capsules or another antidepressant may precipitate a mixed/manic episode. Use cautiously in patients with bipolar disorder. Prior to initiating treatment with Drizalma Sprinkle™, screen patients for any personal or family history of bipolar disorder, mania, or hypomania. Angle-Closure Glaucoma: Duloxetine may trigger an angle-closure attack in patients with anatomically narrow angles who do not have a patent iridectomy. Avoid use of antidepressants, including Drizalma Sprinkle™, in patients with anatomically narrow angles. Seizures: Drizalma Sprinkle™ should be prescribed with care in patients with a history of seizure disorder. Blood Pressure: Monitor blood pressure prior to initiating treatment and periodically throughout treatment. Hyponatremia: Can occur in association with SIADH. Cases of hyponatremia have been reported. Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose and HbA1c have been observed. ADVERSE REACTIONS The most common adverse reactions (≥5% and at least twice the incidence of placebo patients) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis. DOSING AND ADMINISTRATION Drizalma Sprinkle™ may be taken with or without food. Drizalma Sprinkle™ may be swallowed whole (do not crush or chew capsule); opened and sprinkled over applesauce; or administered via nasogastric tube. DRUG INTERACTIONS Avoid concomitant use with potent CYP1A2 inhibitors. Consider dose reduction with concomitant use with CYP2D6 substrates. USE IN SPECIFIC POPULATIONS Hepatic Impairment: Avoid use in patients with mild, moderate, or severe hepatic impairment. Renal Impairment: Avoid use in patients with severe renal impairment. Pregnancy: Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Drizalma Sprinkle™. Third trimester use may increase risk of symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate. Please see Full Prescribing Information by clicking here. Disclaimer Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. About Sun Pharmaceutical Industries Inc., USA Sun Phrama is a wholly owned subsidiary of Sun Pharmaceutical Industries, Limited (SPIL). SPIL is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. SPIL fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 6% of annual revenues in R&D. For further information, please visit & follow us on Twitter @SunPharma_Live

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