Vilazodone

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Vilazodone
Vilazodone.svg
Names
Pronunciation/ˈvbrɪd/ VY-brid
Trade namesViibryd
Other namesEMD-68843; SB-659746A
Clinical data
Drug classSerotonin modulator[1]
Pregnancy
category
  • US: C (Risk not ruled out)
Routes of
use
By mouth
Defined daily dosenot established[2]
External links
AHFS/Drugs.comMonograph
MedlinePlusa611020
Legal
License data
Legal status
Pharmacokinetics
Bioavailability72% (oral, with food)[3]
MetabolismHepatic via CYP3A4[3]
Elimination half-life25 hours[3]
ExcretionFaecal and renal[3]
Chemical and physical data
FormulaC26H27N5O2
Molar mass441.535 g·mol−1
3D model (JSmol)
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Vilazodone, sold under the brand name Viibryd among others, is a medication used to treat major depressive disorder.[1] While it was being studied for generalized anxiety disorder, such research had stopped as of 2017.[4] It is taken by mouth.[1]

Common side effects include nausea, diarrhea, and trouble sleeping.[1] Serious side effects may include increased suicidal thoughts or actions in those under the age of 25, serotonin syndrome, bleeding, mania, and SIADH.[1] A withdrawal syndrome may occur if the dose is rapidly decreased.[1] Use during pregnancy and breastfeeding is not generally recommended.[5] It is in the serotonin modulator class of medications and is believed to work both as an SSRI and activator of the 5-HT1A receptor.[1]

Vilazodone was approved for medical use in the United States in 2011[1] and in Canada in 2018.[6] In the United States the wholesale cost for a month of medication is about US$261.[7] In 2017, it was the 285th most commonly prescribed medication in the United States, with more than one million prescriptions.[8][9]

Medical uses

According to two eight-week trials in adults, vilazodone has an antidepressant response after one week of treatment. After eight weeks it resulted in a 13% greater response than placebo. Remission rates, however, were not significantly different versus placebo.[10]

According to FDA staff, "it is unknown whether vilazodone has any advantages compared to other drugs in the antidepressant class."[11]

Development for generalized anxiety disorder (GAD) has been stopped as of 2017.[4] While there is tentative evidence of a small benefit in GAD there is a high rate of side effects.[12]

Dosage

The defined daily dose is not established[2]

Side effects

In 2016, the FDA required the adding to the label the link with acute pancreatitis.[13]

After a one-year, open-label study assessing the safety and tolerability of vilazodone in people with major depressive disorder, the most common adverse effects were diarrhea (35.7%), nausea (31.6%), and headache (20.0%); greater than 90% of these adverse effects were mild or moderate.[10] In randomized controlled trials, meanwhile, these rates were 28%, 23.4% and 13.3%, respectively.[10] In contrast to other SSRIs, initial trials showed that vilazodone did not cause decreased sexual desire/function, which often cause people to abandon their use.[14] Incidence of adverse effects include:[3]

Very common adverse effects (incidence >10%)
  • Nausea
  • Diarrhea
  • Headache
Common adverse effects (1–10% incidence)
Uncommon adverse effects (0.1–1% incidence)
Rare adverse effects (<0.1% incidence)
  • Serotonin syndrome—a serious adverse effect characterised by:
    • Nausea
    • Vomiting
    • Mental status change (e.g. confusion, hallucinations, agitation, coma, stupor)
    • Muscle rigidity
    • Tremor
    • Myoclonus
    • Hyperreflexia—overresponsive/overactive reflexes
    • Hyperthermia—elevated body temperature
    • Autonomic instability (e.g. tachycardia, dizziness, abnormally excessive sweating, etc.)
  • Mania/hypomania—a potentially dangerously elated/agitated mood. Every antidepressant has the potential to induce these psychiatric reactions. They are particularly problematic in those with a history of hypomania/mania such as those with bipolar disorder.[15]
Unknown-incidence adverse effects
  • Suicidal ideation—all antidepressants can cause suicidal ideation especially in young adults and adolescents under the age of 25.
  • Abnormal bleeding—the SSRIs are known for their ability to increase the incidence of gastrointestinal bleeds and other bleeding abnormalities.[15][16][17]
  • Seizures
  • Syndrome of inappropriate antidiuretic hormone secretion (SIADH)—a condition characterised by an abnormally excessive secretion of antidiuretic hormone causing potentially-fatal electrolyte abnormalities (such as hyponatraemia).
  • Hyponatraemia (a complication of the former)—low blood sodium.

Pregnancy

Antidepressant exposure (including vilazodone) is associated with shorter average duration of pregnancy (by three days), increased risk of preterm delivery (by 55%), lower birth weight (by 75 g), and lower Apgar scores (by <0.4 points).[18][19] It is uncertain whether there is an increased rate of septal heart defects among children whose mothers were prescribed an SSRI in early pregnancy.[20][21]

Pharmacology

Vilazodone acts as a serotonin reuptake inhibitor (IC50 = 2.1 nM; Ki = 0.1 nM) and 5-HT1A receptor partial agonist (IC50 = 0.2 nM; IA = ~60–70%).[10][22] It has negligible affinity for other serotonin receptors such as 5-HT1D, 5-HT2A, and 5-HT2C.[22][23] It also exhibits clinically unimportant inhibitory activity at the norepinephrine and dopamine transporters (Ki = 56 nM for NET and 37 nM for DAT).[3] Vilazodone is best absorbed with food and has a bioavailability of 72% under fed conditions. The Cmax increased between 147%-160% and the AUC increased between 64%-85% of vilazodone when it was administered with either a fatty or light meal.[24]

History

It was developed by Merck KGaA and licensed by Clinical Data, a biotech company purchased by Forest Laboratories in 2011.[25]

See also

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 "Vilazodone Hydrochloride Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Retrieved 3 March 2019.
  2. 2.0 2.1 "WHOCC - ATC/DDD Index". www.whocc.no. Retrieved 10 September 2020.
  3. 3.0 3.1 3.2 3.3 3.4 3.5 "VIIBRYD (vilazodone hydrochloride) tablet VIIBRYD (vilazodone hydrochloride) kit [Forest Laboratories, Inc.]". DailyMed. Forest Laboratories, Inc. December 2012. Archived from the original on 29 October 2013. Retrieved 28 October 2013.
  4. 4.0 4.1 "New Medicines Newsletter" (PDF). NHS. Retrieved 21 March 2019.
  5. "Vilazodone (Viibryd) Use During Pregnancy". Drugs.com. Retrieved 21 March 2019.
  6. Government of Canada, Health Canada (25 April 2012). "Drug Product Database Online Query". health-products.canada.ca. Retrieved 18 May 2020.
  7. "NADAC as of 2019-02-27". Centers for Medicare and Medicaid Services. Retrieved 3 March 2019.
  8. "The Top 300 of 2020". ClinCalc. Retrieved 11 April 2020.
  9. "Vilazodone Hydrochloride - Drug Usage Statistics". ClinCalc. Retrieved 11 April 2020.
  10. 10.0 10.1 10.2 10.3 Wang SM, Han C, Lee SJ, Patkar AA, Masand PS, Pae CU (August 2013). "A review of current evidence for vilazodone in major depressive disorder". International Journal of Psychiatry in Clinical Practice. 17 (3): 160–9. doi:10.3109/13651501.2013.794245. PMID 23578403.
  11. Laughren TP, Gobburu J, Temple RJ, Unger EF, Bhattaram A, Dinh PV, Fossom L, Hung HM, Klimek V, Lee JE, Levin RL, Lindberg CY, Mathis M, Rosloff BN, Wang SJ, Wang Y, Yang P, Yu B, Zhang H, Zhang L, Zineh I (September 2011). "Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant". The Journal of Clinical Psychiatry. 72 (9): 1166–73. doi:10.4088/JCP.11r06984. PMID 21951984.
  12. Zareifopoulos N, Dylja I (April 2017). "Efficacy and tolerability of vilazodone for the acute treatment of generalized anxiety disorder: A meta-analysis". Asian Journal of Psychiatry. 26: 115–122. doi:10.1016/j.ajp.2017.01.016. PMID 28483071.
  13. "SUPPLEMENT APPROVAL" (PDF). FDA.
  14. "FDA approves Clinical Data Inc's antidepressant". Reuters. January 22, 2011. Archived from the original on January 27, 2011.
  15. 15.0 15.1 Australian Medicines Handbook 2013. The Australian Medicines Handbook Unit Trust; 2013.
  16. Taylor D, Paton C, Kapur S, Taylor D. The Maudsley prescribing guidelines in psychiatry. 11th ed. Chichester, West Sussex: John Wiley & Sons; 2012.
  17. Wang Y-P, Chen Y-T, Tsai C-F, Li S-Y, Luo J-C, Wang S-J, et al. Short-Term Use of Serotonin Reuptake Inhibitors and Risk of Upper Gastrointestinal Bleeding. Am J Psychiatry [Internet]. 2013 Sep 13 [cited 2013 Oct 6]; Available from: http://ajp.psychiatryonline.org/article.aspx?articleid=1738031
  18. Ross LE, Grigoriadis S, Mamisashvili L, Vonderporten EH, Roerecke M, Rehm J, Dennis CL, Koren G, Steiner M, Mousmanis P, Cheung A (April 2013). "Selected pregnancy and delivery outcomes after exposure to antidepressant medication: a systematic review and meta-analysis". JAMA Psychiatry. 70 (4): 436–43. doi:10.1001/jamapsychiatry.2013.684. PMID 23446732.
  19. Lattimore, Keri A; Donn, Steven M; Kaciroti, Niko; Kemper, Alex R; Neal, Charles R; Vazquez, Delia M (14 July 2005). "Selective Serotonin Reuptake Inhibitor (SSRI) Use during Pregnancy and Effects on the Fetus and Newborn: A Meta-Analysis". Journal of Perinatology. 25 (9): 595–604. doi:10.1038/sj.jp.7211352. PMID 16015372.
  20. Pedersen LH, Henriksen TB, Vestergaard M, Olsen J, Bech BH (September 2009). "Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study". BMJ. 339 (sep23 1): b3569. doi:10.1136/bmj.b3569. PMC 2749925. PMID 19776103.
  21. Huybrechts KF, Palmsten K, Avorn J, Cohen LS, Holmes LB, Franklin JM, Mogun H, Levin R, Kowal M, Setoguchi S, Hernández-Díaz S (June 2014). "Antidepressant use in pregnancy and the risk of cardiac defects". The New England Journal of Medicine. 370 (25): 2397–407. doi:10.1056/NEJMoa1312828. PMC 4062924. PMID 24941178.
  22. 22.0 22.1 Hughes ZA, Starr KR, Langmead CJ, Hill M, Bartoszyk GD, Hagan JJ, Middlemiss DN, Dawson LA (March 2005). "Neurochemical evaluation of the novel 5-HT1A receptor partial agonist/serotonin reuptake inhibitor, vilazodone". European Journal of Pharmacology. 510 (1–2): 49–57. doi:10.1016/j.ejphar.2005.01.018. PMID 15740724.
  23. Page ME, Cryan JF, Sullivan A, Dalvi A, Saucy B, Manning DR, Lucki I (September 2002). "Behavioral and neurochemical effects of 5-(4-[4-(5-Cyano-3-indolyl)-butyl)-butyl]-1-piperazinyl)-benzofuran-2-carboxamide (EMD 68843): a combined selective inhibitor of serotonin reuptake and 5-hydroxytryptamine(1A) receptor partial agonist". The Journal of Pharmacology and Experimental Therapeutics. 302 (3): 1220–7. doi:10.1124/jpet.102.034280. PMID 12183683.
  24. Cruz MP (January 2012). "Vilazodone HCl (Viibryd): A Serotonin Partial Agonist and Reuptake Inhibitor For the Treatment of Major Depressive Disorder". P & T. 37 (1): 28–31. PMC 3278186. PMID 22346333.
  25. "Xconomy: Blend Therapeutics Taps Former Clinical Data Chief Fromkin As New CEO". xconomy.com. 13 April 2015. Archived from the original on 9 September 2017. Retrieved 6 May 2018.

External links

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