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Brintellix ™ - Vortioxetine

Brintellix ™ - Vortioxetine. Manufacturer: Takeda FDA Approval Date: September 30, 2013. Brintellix ™ - vortioxetine Clinical Application. Indications: Major Depressive Disorder (MDD) Place in therapy: For those with MDD who have failed other drug therapies

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Brintellix ™ - Vortioxetine

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  1. Brintellix™ - Vortioxetine Manufacturer: Takeda FDA Approval Date: September 30, 2013

  2. Brintellix™ - vortioxetineClinical Application • Indications: • Major Depressive Disorder (MDD) • Place in therapy: • For those with MDD who have failed other drug therapies • Recently, research has come out indicating that vortioxetine may have a cognitive benefit in patients with MDD

  3. Brintellix™ - vortioxetineClinical Application • Contraindications: • Hypersensitivity • Use of MAOIs concurrently, within 21 days of discontinuing vortioxetine, or within 14 days of discontinuing the MAOI • Black Box Warning: • Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (<25) with MDD

  4. Brintellix™ - vortioxetineClinical Application • Warnings and Precautions • Increased bleeding risk due to impaired platelet aggregation • Increased risk of serotonin syndrome • Increased risk of SIADH and hyponatremia • May precipitate a mixed/manic episode in bipolar patients • May cause CNS depression • Angioedema has been reported

  5. Brintellix™ - vortioxetineClinical Application • Pregnancy: • Category C • Lactation: • Excretion in breast milk is unknown; use is not recommended

  6. Brintellix™ - vortioxetineDrug Facts • Pharmacology: • selective serotonin inhibitor • 5-HT1A receptor agonist • partial agonist of 5HT1B • antagonist of 5-HT3 , 5-HT1D, and 5HT7 receptors

  7. Brintellix™ - vortioxetineDrug Facts • Pharmacokinetics:

  8. Brintellix™ - vortioxetineDrug Interactions • Drug Interactions – Precipitant Drugs: • CYP2D6 inhibitors  vortioxetine concentrations • CYP3A4 inducers  vortioxetine concentrations

  9. Brintellix™ - vortioxetineAdverse Effects

  10. Brintellix™ - vortioxetineMonitoring Parameters • Efficacy Monitoring: • Symptom improvement • Toxicity Monitoring: • Monitor for signs and symptoms of serotonin syndrome • Monitor for hyponatremia

  11. Brintellix™ - vortioxetinePrescription Information • Dosing: 5 mg to 20 mg daily • Initial: 10 mg daily • Max: 20 mg daily • Cost: $258 for #30 • Same price for all strengths • Walmart Pharmacy contacted 12/26/2013

  12. Brintellix™ - vortioxetineLiterature Review • A multicenter, double-blind, randomized, placebo-controlled, parallel-group, phase 3 study • [1mg] [5mg] [10mg] [placebo] • Primary Endpoint • Reduction in 24-item Hamilton Depression Rating Scale (HDRS-24) total score Henigsberg N, et al. J Clin Psychiatry. 2012;73:953-59

  13. Brintellix™ - vortioxetineLiterature Review • Secondary Endpoints • Response and remission rates • Sheehan Disability Scale (SDS) • Clinical Global Impressions-Global Improvement scale (CGI-I) • MADRS total score • HDRS-24 total score in subjects with baseline Hamilton Anxiety Rating Scale (HARS) score >20 Henigsberg N, et al. J Clin Psychiatry. 2012;73:953-59

  14. Brintellix™ - vortioxetineLiterature Review • N = 560 • Age 18-75 (average age 46) • MDD of at least 3 months’ duration • MADRS total score > 26 • Patients considered at a significant risk of suicide, had other psychiatric or neurologic conditions, or substance abuse history, or another significant medical illness Henigsberg N, et al. J Clin Psychiatry. 2012;73:953-59

  15. Brintellix™ - vortioxetineLiterature Review Henigsberg N, et al. J Clin Psychiatry. 2012;73:953-59

  16. Brintellix™ - vortioxetineLiterature Review Primary Outcome: Henigsberg N, et al. J Clin Psychiatry. 2012;73:953-59

  17. Brintellix™ - vortioxetineLiterature Review Secondary Outcomes: Henigsberg N, et al. J Clin Psychiatry. 2012;73:953-59

  18. Brintellix™ - vortioxetineIn the News • December 10, 2013: FOCUS • Brintellix was superior to placebo in a composite score of two tests (p<0.0001) • Digit Symbol Substitution Test (DSST) • Rey Auditory Verbal Learning Test (RAVLT) • Both of these tests measure cognitive function in adults with MDD • Patients on Brintellix had improved executive function, speed of processing and attention McIntyre RS, Lophaven S, Olsen CK. Randomized, double-blind, placebo-controlled study of the efficacy of vortioxetine on cognitive dysfunction in adult patients with major depressive disorder (MDD). Neuropsychopharmacology 2013;38:S380-S381 . [Conference abstract] Abstract T160

  19. Brintellix™ - vortioxetineSummary • Brintellix is indicated for treatment of major depressive disorder • The initial dose is typically 10 mg and can be increased to 20 mg as tolerated • Nausea is the most common side effect • Monitor for serotonin syndrome and SIAD/hyponatremia

  20. Brintellix™ - vortioxetineReferences • http://www.us.brintellix.com • Boulenger JP, et al. J Psychopharmacol. 2012;26:1408-16 • Brintellix [package insert]. Deerfield, IL: Takeda Pharmaceuticals Inc.; September 2013. • Henigsberg N, et al. J Clin Psychiatry. 2012;73:953-59 • McIntyre RS, Lophaven S, Olsen CK. Randomized, double-blind, placebo-controlled study of the efficacy of vortioxetine on cognitive dysfunction in adult patients with major depressive disorder (MDD). Neuropsychopharmacology 2013;38:S380-S381. [Conference abstract] Abstract T160

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