Desvenlafaxine: A new serotonin-norepinephrine reuptake inhibitor for the treatment of adults with major depressive disorder

Perry, Richard; Cassagnol, Manouchkathe

doi:10.1016/j.clinthera.2009.07.012

Cited by 48 publications

(55 citation statements)

References 25 publications

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“…A proporção de pacientes com três ou mais consultas é de 40,8% entre os que apresentavam o quadro em comparação a 26,1% naqueles que não apresentavam a doença (Huang et al, 2014 No que diz respeito à farmacocinética da desvenlafaxina, a t 1/2 teve valor próximo ao descrito na bula do medicamento referência e na literatura científica em ambas as condições de administração (Andrade, 2009;Perry & Cassagnol, 2009;Pfizer, 2015), indicando que o desenho do estudo foi adequado para avaliar a farmacocinética da desvenlafaxina, principalmente na fase de eliminação.…”

Section: Discussionunclassified

“…A desvenlafaxina é um metabólito ativo da venlafaxina (O-desmetilvenlafaxina) e pertence à classe dos inibidores da recaptação de serotonina e norepinefrina (Andrade, 2009;Perry & Cassagnol, 2009). Em fevereiro de 2008, a agência regulatória americana (Food and Drug Administration) aprovou o fármaco para o tratamento do Transtorno Depressivo Maior (TDM) em adultos (Center for Drug Evaluation and Research, 2008).…”

Section: Introductionunclassified

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Avaliação da bioequivalência entre duas formulações de succinato de desvenlafaxina monoidratado – 50 mg comprimido revestido de liberação prolongada – administradas em jejum e pós-prandial em voluntários sadios de ambos os sexos

Predrazzoli-Júnior¹,

Calafati²,

Coelho³

et al. 2017

JBES

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Avaliação da bioequivalência entre duas formulações de succinato de desvenlafaxina monoidratado -50 mg comprimido revestido de liberação prolongadaadministradas em jejum e pós-prandial em voluntários sadios de ambos os sexos Cada estudo foi conduzido de maneira independente, sendo ambos do tipo aberto, dois períodos, utilizando um delineamento do tipo crossover 2x2, envolvendo 48 voluntários, com intervalo de sete dias entre os períodos (washout). Resultados: Na administração em jejum, a razão entre a média geométrica da formulação teste e referência (T/R) de C máx foi 107,49%, com intervalo de confiança (IC) 90% de 100,81 a 114,60%. Para ASC 0-t , a razão T/R foi de 104,90%, com IC 90% de 97,53 a 112,82%. Na administração pós-prandial, a razão T/R de C máx foi 103,17%, com IC 90% de 95,08 a 111,94%. Para ASC 0-t , a razão T/R foi 103,40%, com IC 90% de 94,97 a 112,58%. Conclusões: As formulações teste e referência foram consideradas estatisticamente bioequivalentes em ambas as condições de administração, jejum e pós-prandial, de acordo com os critérios exigidos pela Agência Nacional de Vigilância Sanitária (Anvisa). A formulação teste foi o primeiro medicamento similar (Zodel®, 50 e 100 mg) registrado pela Anvisa nessa categoria e disponibilizado para comercialização, contribuindo assim com a ampliação da disponibilidade do tratamento para o transtorno depressivo maior e a redução de custos ao paciente. In the fasted administration, the ratio between the geometrical mean of test formulation and reference (T/R) of C max was 107.49%, with confidence interval 90% (CI 90%) of 100.81 to 114.60%. For AUC 0-t, the ratio T/R was of 104.90%, with CI 90% from 97.53% to 112.82%. In the fed administration, the ratio T/R of C max was 103.17% with CI 90% of 95.08 to 111.94%. For AUC 0-t, the ratio T/R was 103.40%, with CI 90% of 94.97 to 112.58%. Conclusions: The test and reference formulations were considered statistically bioequivalent in the two administration conditions, fasted and fed, according to the requirements of Brazilian National Health Surveillance Agency (Anvisa). The test formulation was the first similar medicine (Zodel®, 50 e 100 mg) to be registered by Anvisa in this category and available to commercialization, thus contributing to increase the availability of treatment for major depressive disorder and the reduction of costs to the patient.

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Section: Discussionunclassified

Section: Introductionunclassified

Avaliação da bioequivalência entre duas formulações de succinato de desvenlafaxina monoidratado – 50 mg comprimido revestido de liberação prolongada – administradas em jejum e pós-prandial em voluntários sadios de ambos os sexos

Predrazzoli-Júnior¹,

Calafati²,

Coelho³

et al. 2017

JBES

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“…It has linear kinetics in the 100 to 600 mg/day range, although its antidepressant efficacy has been demonstrated with 50 mg/day doses. Its oral Bioavailability is 80% and it is not modified by low fat meals [4,5]. It is mainly metabolized by glucuronidation through UDP-glucuronyltransferase and to a lesser extent through the cytochrome CYP3A4 oxidative pathway.…”

Section: Introductionmentioning

confidence: 99%

“…The major depressive disorder is a mental disease with a high prevalence in adult population (close to 7%) and a prediction of becoming the main world disability cause by 2030 [5,6]. This pathology has an adverse impact in patients with related diseases, such as cardiovascular disease and chronic pain handling, being the pharmacological treatment the main support for its treatment.…”

Section: Introductionmentioning

confidence: 99%

“…It was approved in 2008 by the FDA for the Major Depressive Disorder (MDD) treatment given its short-term safety, tolerability and demonstrated efficacy in placebo-controlled trials [1][2][3]. In its succinate salt form, an extended active ingredient release is produced, allowing the administration of one tablet every 24 hours since it has a plasma concentration peak at 6 to 8 hours in fasting conditions (8 to 10 hours if taken postprandial) and an elimination half-life between 9 to 15 hours [4,5]. It has linear kinetics in the 100 to 600 mg/day range, although its antidepressant efficacy has been demonstrated with 50 mg/day doses.…”

Section: Introductionmentioning

confidence: 99%

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Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

Jba¹

2014

J Bioequiv Availab

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The Pharmacokinetics and Bioequivalence of Desvenlafaxine Succinate in Chinese Healthy Subjects Under Fasting and Fed States

Wang,

Yang,

et al. 2023

Clinical Pharm in Drug Dev

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Desvenlafaxine succinate is a selective serotonin–norepinephrine reuptake inhibitor for the treatment of major depressive disorder. The pharmacokinetic profile of desvenlafaxine succinate at the clinically recommended dose of 50 mg in Chinese healthy subjects has been reported rarely. The objective of this study was to evaluate the pharmacokinetics and bioequivalence of desvenlafaxine succinate in Chinese healthy subjects. A single‐dose, open‐label, randomized, two‐way crossover study with a 7‐day washout period was conducted. A total of 88 individuals were incorporated to show bioequivalence of a generic and a reference drug, with 48 individuals in the fasting state and 40 receiving a high‐fat diet. Finally, 46 and 38 individuals completed the fasting and the fed study, respectively. The 90% confidence intervals of the adjusted geometric mean ratios for maximum plasma concentration, area under the concentration–time curve from time zero to the last measurable concentration, and area under the concentration–time curve from time zero to infinity all fell in the bioequivalent interval of 80%–125% in both the fasting and fed states. A total of 33 adverse events were reported, and all were mild or moderate in severity. In summary, the generic and reference formulations were bioequivalent, with no observable safety differences in the fasting/fed state.

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Desvenlafaxine: A new serotonin-norepinephrine reuptake inhibitor for the treatment of adults with major depressive disorder

Cited by 48 publications

References 25 publications

Avaliação da bioequivalência entre duas formulações de succinato de desvenlafaxina monoidratado – 50 mg comprimido revestido de liberação prolongada – administradas em jejum e pós-prandial em voluntários sadios de ambos os sexos

Avaliação da bioequivalência entre duas formulações de succinato de desvenlafaxina monoidratado – 50 mg comprimido revestido de liberação prolongada – administradas em jejum e pós-prandial em voluntários sadios de ambos os sexos

Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

The Pharmacokinetics and Bioequivalence of Desvenlafaxine Succinate in Chinese Healthy Subjects Under Fasting and Fed States

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