Vilazodone

Source: Wikipedia, the free encyclopedia.

Vilazodone
Clinical data
Pronunciation/vɪˈlæzədoʊn/
vi-LAZ-ə-dohn
Trade namesViibryd
Other namesEMD-68843; SB-659746A
AHFS/Drugs.comMonograph
MedlinePlusa611020
License data
Serotonin modulator[1]
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability72% (oral, with food)[5]
MetabolismLiver via CYP3A4[5]
Elimination half-life25 hours[5]
ExcretionFaecal and renal[5]
Identifiers
  • 5-(4-[4-(5-Cyano-1H-indol-3-yl)butyl]piperazin-1-yl)benzofuran-2-carboxamide
JSmol)
  • N#Cc5ccc4[nH]cc(CCCCN3CCN(c2ccc1oc(C(N)=O)cc1c2)CC3)c4c5
  • InChI=1S/C26H27N5O2/c27-16-18-4-6-23-22(13-18)19(17-29-23)3-1-2-8-30-9-11-31(12-10-30)21-5-7-24-20(14-21)15-25(33-24)26(28)32/h4-7,13-15,17,29H,1-3,8-12H2,(H2,28,32) checkY
  • Key:SGEGOXDYSFKCPT-UHFFFAOYSA-N checkY
 ☒NcheckY (what is this?)  (verify)

Vilazodone, sold under the brand name Viibryd among others, is a

serotonin modulator[1] and is taken by mouth.[1]

Common side effects include nausea, diarrhea, and trouble sleeping.

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.[8] In 2019, it was the 334th most commonly prescribed medication in the United States, with more than 900 thousand prescriptions.[9] The drug lost patent protection in June 2022 for adults and in July 2023 for pediatrics.[10] Generic versions have been approved by the U.S. Food and Drug Administration (FDA).[11][12]

Medical uses

Seven controlled efficacy trials were conducted of vilazodone for treatment of major depressive disorder (MDD).[13] Five of these trials showed no significant influence of vilazodone over placebo on depressive symptoms.[13] In the remaining two trials, small but significant advantages of vilazodone over placebo were found.[13] According to these two eight-week trials in adults, vilazodone has an antidepressant response after one week of treatment.[14] After eight weeks it resulted in a 13% greater response than placebo.[14] Remission rates, however, were not significantly different versus placebo.[14]

According to the US Food and Drug Administration (FDA) staff in 2011, "it is unknown whether vilazodone has any advantages compared to other drugs in the antidepressant class."[15] A 2019 review stated that "present studies do not suggest the superiority of vilazodone compared with other antidepressants."[16]

Development of vilazodone for generalized anxiety disorder (GAD) has been stopped as of 2017.[17] While there is tentative evidence of a small benefit in GAD, there is a high rate of side effects.[18]

Adverse effects

In September 2016, the FDA wrote a letter to Forest Labs requiring a new warning to be added to the label related to a link between the drug and acute pancreatitis and sleep paralysis.[19]

After a one-year,

SSRIs, initial trials showed that vilazodone did not cause decreased sexual desire/function, which often cause people to abandon their use.[20] Additionally, vilazodone may cause less emotional blunting than typical SSRIs and SNRIs.[6]
Incidence of adverse effects include:[5]

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.[21]
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.[21][22][23]
  • Seizures
  • 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).[24][25] It is uncertain whether there is an increased rate of septal heart defects among children whose mothers were prescribed an SSRI in early pregnancy.[26][27]

Pharmacology

Pharmacodynamics

Vilazodone acts as a

occupancy of the 5-HT1A receptor with vilazodone, whereas occupancy of the SERT by vilazodone in humans does not seem to have been studied.[30][31][32]

Pharmacokinetics

Vilazodone is best absorbed with food and has a bioavailability of 72% under fed conditions. The Cmax increased between 147 and 160% and the AUC increased between 64 and 85% of vilazodone when it was administered with either a fatty or light meal.[33]

History

It was developed by

Merck KGaA and licensed by Clinical Data, a biotech company purchased by Forest Laboratories in 2011.[34]

References

  1. ^ a b c d e f g h i "Vilazodone Hydrochloride Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Retrieved March 3, 2019.
  2. ^ Anvisa (March 31, 2023). "RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published April 4, 2023). Archived from the original on August 3, 2023. Retrieved August 16, 2023.
  3. ^ "Viibryd Product information". Health Canada. April 25, 2012. Retrieved June 10, 2022.
  4. ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. May 4, 2016. Retrieved April 7, 2024.
  5. ^ a b c d e f g "Viibryd (vilazodone hydrochloride) tablet Viibryd (vilazodone hydrochloride) kit [Forest Laboratories, Inc.]". DailyMed. Forest Laboratories, Inc. December 2012. Archived from the original on October 29, 2013. Retrieved October 28, 2013.
  6. ^
    S2CID 4572360
    .
  7. ^ "Vilazodone (Viibryd) Use During Pregnancy". Drugs.com. Retrieved March 21, 2019.
  8. ^ "Drug Product Database Online Query". Health Canada. Government of Canada. April 25, 2012. Retrieved May 18, 2020.
  9. ^ "Vilazodone - Drug Usage Statistics". ClinCalc. Archived from the original on July 8, 2020. Retrieved October 16, 2021.
  10. ^ "Generic Viibryd Availability".
  11. ^ "Vilazodone: FDA-Approved Drugs".
  12. ^ "2019 First Generic Drugs Approvals". U.S. Food and Drug Administration (FDA). January 21, 2021. Retrieved June 10, 2022.
  13. ^
    PMID 25279271
    .
  14. ^
    S2CID 10702028
    .
  15. PMID 21951984
    .
  16. S2CID 53773793
    .
  17. ^ "New Medicines Newsletter" (PDF). NHS. Archived from the original (PDF) on March 21, 2019. Retrieved March 21, 2019.
  18. PMID 28483071
    .
  19. ^ "SUPPLEMENT APPROVAL" (PDF). U.S. Food and Drug Administration (FDA).
  20. ^ "FDA approves Clinical Data Inc's antidepressant". Reuters. January 22, 2011. Archived from the original on January 27, 2011.
  21. ^ a b Australian Medicines Handbook 2013. The Australian Medicines Handbook Unit Trust; 2013.
  22. ^ Taylor D, Paton C, Kapur S, Taylor D. The Maudsley prescribing guidelines in psychiatry. 11th ed. Chichester, West Sussex: John Wiley & Sons; 2012.
  23. ^ 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
  24. PMID 23446732
    .
  25. PMID 16015372
    .
  26. PMID 19776103
    .
  27. PMID 24941178
    .
  28. ^
    PMID 15740724
    .
  29. S2CID 12020750
    .
  30. S2CID 19662281
    .
  31. PMID 19499624
    .
  32. PMID 22935937
    .
  33. PMID 22346333
    .
  34. ^ "Xconomy: Blend Therapeutics Taps Former Clinical Data Chief Fromkin As New CEO". xconomy.com. April 13, 2015. Archived from the original on September 9, 2017. Retrieved May 6, 2018.
Retrieved from "https://en.wikipedia.org/w/index.php?title=Vilazodone&oldid=1218181795"