Out Of The Pipeline

Vilazodone for major depressive disorder

Current Psychiatry. 2011 April;10(4):84-88

References

1. Bartoszyk GD, Hegenbart R, Ziegler H. EMD 68843 a serotonin reuptake inhibitor with selective presynaptic 5-HT1A receptor agonistic properties. Eur J Pharmacol. 1997;322(2-3):147-153.

2. de Paulis T. Drug evaluation: vilazodone—a combined SSRI and 5-HT1A partial agonist for the treatment of depression. IDrugs 2007;10(3):193-201.

3. Viibryd [package insert]. New Haven CT: Trovis Pharmaceuticals, LLC; 2011.

4. Heinrich T, Böttcher H, Schiemann K, et al. Dual 5-HT1A agonists and 5-HT re-uptake inhibitors by combination of indole-butyl-amine and chromenonyl-piperazine structural elements in a single molecular entity. Bioorg Med Chem. 2004;12(18):4843-4852.

5. Blier P, Ward NM. Is there a role for 5-HT1A agonists in the treatment of depression? Biol Psychiatry. 2003;53:193-203.

6. Bielski RJ, Cunningham L, Horrigan JP, et al. Gepirone extended-release in the treatment of adult outpatients with major depressive disorder: a double-blind, randomized, placebo-controlled, parallel-group study. J Clin Psychiatry. 2008;69:571-577.

7. Gammans RE, Stringfellow JC, Hvizdos AJ, et al. Use of buspirone in patients with generalized anxiety disorder and coexisting depressive symptoms. A meta-analysis of eight randomized, controlled studies. Neuropsychobiology. 1992;25:193-201.

8. Robinson DS, Rickels K, Feighner J, et al. Clinical effects of the 5-HT1A partial agonists in depression: a composite analysis of buspirone in the treatment of depression. J Clin Psychopharmacol. 1990;10(3 suppl):67S-76S.

9. Rickels K, Athanasiou M, Robinson DS, et al. Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009;70(3):326-333.

10. Khan A, Cutler AJ, Kajdasz DK, et al. Efficacy and tolerability of vilazodone, a dual-acting serotonergic antidepressant, in the treatment of patients with MDD. Poster presented at: American Psychiatric Association Annual Meeting; New Orleans, LA; May 25, 2010.

11. Mittal MS, Kalia R, Preskorn SH. Vilazodone a 5-HT1A receptor partial agonist and serotonin reuptake pump inhibitor: what can be gleaned from its history and its clinical data? J Psychiatr Pract. In press.

12. Robinson D, Kajdasz D, Gallipoli S, et al. A one-year open-label study assessing the safety and tolerability of vilazodone in patients with MDD. Poster presented at: American Psychiatric Association Annual Meeting: New Orleans, LA; May 25, 2010.

13. Preskorn SH, Flockhart D. 2010 guide to psychiatric drug interactions. Primary Psychiatry. 2009;16(12):45-74.

Clinical Point

Dose should be reduced to 20 mg/d when vilazodone is coadministered with strong CYP3A4 inhibitors

Dose should be reduced to 20 mg/d when vilazodone is coadministered with strong CYP3A4 inhibitors, such as azole antifungals, macrolides, protease inhibitors, and verapamil.¹³ No dosage adjustment is recommended based on age, mild or moderate liver impairment, or renal impairment of any severity.³ Vilazodone has not been studied in patients with severe hepatic impairment.³

How does vilazodone compare?

Ideally, it would be good to know how vilazodone compares with other marketed antidepressants. Unfortunately, there are no published head-to-head comparison data to address this matter. The number needed to treat with vilazodone is between 7 and 8 based on the data from the 2 phase III trials (Table 2).^9-11 This is comparable to other antidepressants. One phase III study showed a statistically greater reduction in depressive symptomatology in vilazodone-treated patients after 1 week, ⁹ but that was not replicated in the second trial.¹⁰

Related Resources

Khan A. Vilazodone, a novel dual-acting serotonergic antidepressant for managing major depression. Expert Opin Investig Drugs. 2009;18(11):1753-1764.

Drug Brand Names

Ketoconazole • Nizoral
Rifampin • Rifadin
Verapamil • Isoptin
Vilazodone • Viibryd

Disclosures

Drs. Kalia and Mittal report no financial relationship with any company whose products are mentioned in this article, or with manufacturers of competing products.

Since January 2010, Dr. Preskorn has received grant/research support from Abbott Laboratories, Bristol-Myers Squibb, Eli Lilly and Company, Ipsen, Link Medicine, Pfizer Inc, Sunovion, Takeda, and Targacept. He has been a consultant to Abbott Laboratories, Allergan, Biovail, Boehringer Ingelheim, Eisai, Eli Lilly and Company, Evotec Johnson and Johnson, Labopharm, Merck, NovaDel Pharma, Orexigen, Prexa, Psylin Neurosciences Inc., and Sunovion. He is on the speakers bureau of Eisai, Pfizer Inc., and Sunovion.

References

1. Bartoszyk GD, Hegenbart R, Ziegler H. EMD 68843 a serotonin reuptake inhibitor with selective presynaptic 5-HT1A receptor agonistic properties. Eur J Pharmacol. 1997;322(2-3):147-153.

2. de Paulis T. Drug evaluation: vilazodone—a combined SSRI and 5-HT1A partial agonist for the treatment of depression. IDrugs 2007;10(3):193-201.

3. Viibryd [package insert]. New Haven CT: Trovis Pharmaceuticals, LLC; 2011.

5. Blier P, Ward NM. Is there a role for 5-HT1A agonists in the treatment of depression? Biol Psychiatry. 2003;53:193-203.

13. Preskorn SH, Flockhart D. 2010 guide to psychiatric drug interactions. Primary Psychiatry. 2009;16(12):45-74.

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Vilazodone for major depressive disorder

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