In short
Desvenlafaxine is a serotonin and norepinephrine reuptake inhibitor (SNRI), a type of antidepressant authorised for adults with major depressive disorder. It is also being tested in a Phase 3 clinical trial as one of several antidepressants in a personalised medicine strategy for depressive disorder. The trial, authorised in the EU, plans to enrol 240 participants and compares a pre-emptive pharmacogenetic testing approach with standard clinical practice.
Key points
- Desvenlafaxine is an SNRI antidepressant authorised for major depressive disorder in adults.
- The substance is being studied in depressive disorder in a Phase 3 trial.
- The trial plans to enrol 240 participants who are starting a new antidepressant after prior treatment failure.
- Participants in the trial may receive desvenlafaxine as 50 mg prolonged-release tablets taken orally.
- The trial measures symptom remission using depression severity scores (PHQ-9 and MADRS).
- The trial is currently authorised in the EU.
What is desvenlafaxine?
and Sandoz Farmacéutica, S.A. The ATC code for desvenlafaxine is N06AX23, and it is recorded alongside venlafaxine (N06AX16) in the registry.
How does desvenlafaxine work?
Desvenlafaxine works by inhibiting the reuptake of two neurotransmitters in the brain: serotonin and norepinephrine. By blocking their reuptake, the substance increases the availability of these neurotransmitters in the synaptic cleft, which is thought to contribute to its antidepressant effect. The KEGG drug database classifies desvenlafaxine as a serotonin and norepinephrine reuptake inhibitor (SNRI). It is also listed as a substrate for CYP3A/CYP3A4 metabolising enzymes, meaning the body breaks it down partly through these liver enzyme pathways.
Which conditions is desvenlafaxine used or studied for?
- Major depressive disorder (MDD) — desvenlafaxine is authorised for the treatment of adults with this condition, according to the US prescribing information.
- Depressive disorder — the substance is being studied in a Phase 3 trial in patients with depressive disorder who are starting a new antidepressant after prior treatment failure.
How is desvenlafaxine given?
Desvenlafaxine is given as a prolonged-release tablet or prolonged-release hard capsule, taken by oral use. In the trial, the formulation is Desvenlafaxina cinfa 50 mg prolonged-release tablets, with the registry listing a maximum daily dose of 200 mg in the trial context. The US prescribing information gives a recommended dose of 50 mg once daily, with or without food, and states that doses greater than 50 mg per day have not shown additional benefit. A 25 mg per day dose is intended for gradual dose reduction when discontinuing treatment or for patients with severe renal impairment and end-stage renal disease.
What do the clinical trials show?
One Phase 3 clinical trial of desvenlafaxine is listed in the EU Clinical Trials Information System. The trial, titled PREDICT, is authorised and plans to enrol 240 participants with depressive disorder. It evaluates a pre-emptive pharmacogenetic strategy for selecting an antidepressant, comparing it with standard clinical practice in patients starting a new therapy after previous treatment failure. Desvenlafaxine is one of 20 antidepressant drugs included as possible treatments in the trial; other options include mirtazapine, bupropion, quetiapine, amitriptyline, venlafaxine, fluoxetine, sertraline, duloxetine, vortioxetine and escitalopram. The primary outcome is symptom remission, assessed by changes in depression severity scores on the PHQ-9 and MADRS scales after initiation of the new antidepressant. The trial is interventional, meaning participants receive assigned treatments and are followed over time. In addition to this registry record, a published double-blind, randomised, placebo-controlled study assessed desvenlafaxine at 10 mg and 50 mg per day in adult outpatients with major depressive disorder, aiming to establish the lowest effective dose.
What side effects are known?
The US prescribing information for desvenlafaxine carries a boxed warning about an increased risk of suicidal thoughts and behaviours in children, adolescents and young adults taking antidepressants. The label states that patients should be closely monitored for clinical worsening and emergence of suicidal thoughts and behaviours. Desvenlafaxine extended-release tablets are not approved for use in paediatric patients. The published placebo-controlled study assessed the efficacy, safety and tolerability of desvenlafaxine 10 mg and 50 mg per day in adult outpatients with major depressive disorder, though detailed side effect frequencies are not provided in the available source.