Fluvoxamine maleate

Table of contents

• What is fluvoxamine maleate?
• How does fluvoxamine maleate work?
• Which conditions is fluvoxamine maleate used or studied for?
• How is fluvoxamine maleate given?
• What do the clinical trials show?
• What side effects are known?

What is fluvoxamine maleate?

Fluvoxamine maleate is a chemically synthesised substance classified as an antidepressant belonging to the selective serotonin reuptake inhibitor (SSRI) class (ATC code N06AB08).^[3] It is authorised as a medicine, with authorisation records held by Tillomed Laboratories Ltd and Sandoz Farmacéutica, S.A.^[1] The product appears in the trial records as Fluvoxamine 50 mg film-coated tablets and Fluvoxamina Sandoz 50 mg film-coated tablets.^[1] In both registered trials, fluvoxamine maleate is the substance being tested.^[1][2]

How does fluvoxamine maleate work?

Fluvoxamine maleate is a selective serotonin reuptake inhibitor (SSRI).^[4] SSRIs work by increasing the amount of serotonin available in the brain, which is thought to help regulate mood and reduce obsessive thoughts and compulsive behaviours. The US prescribing information states that fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD).^[4]

Which conditions is fluvoxamine maleate used or studied for?

• Obsessive compulsive disorder (OCD) — fluvoxamine maleate is authorised for the treatment of obsessions and compulsions in patients with OCD.^[3][4]
• Depressive disorder — a Phase 3 trial is testing a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder who are starting a new therapy after prior treatment failure.^[2]
• Post-COVID fatigue — a low-intervention trial is testing whether fluvoxamine reduces fatigue severity compared with placebo after 12 weeks of treatment.^[1]

How is fluvoxamine maleate given?

Fluvoxamine maleate is given by oral use as film-coated tablets.^[1] The US prescribing information describes 25 mg, 50 mg and 100 mg immediate-release tablets, and 100 mg and 150 mg extended-release capsules.^[3][4] In the post-COVID trial, fluvoxamine 50 mg film-coated tablets are used at a total daily dose of 200 mg.^[1] In the depression trial, fluvoxamine is listed among several antidepressants at a dose of 300 mg per day.^[2]

What do the clinical trials show?

Two registered clinical trials are investigating fluvoxamine maleate. Both are interventional studies and both are currently authorised.^[1][2]

What are the trials measuring?

The post-COVID trial, called the ESPRIT study, measures fatigue severity using the Checklist Individual Strength (CIS-20R) fatigue score at week 12. The study aims to determine whether fluvoxamine treatment at 50 mg to 200 mg daily results in lower fatigue severity than placebo after 12 weeks.^[1] The depression trial measures symptom remission based on changes in depression severity scores (PHQ-9 and MADRS) after starting a new antidepressant following failure of the prior therapy.^[2]

Who can take part in these trials?

The post-COVID trial enrols 160 participants with post-COVID fatigue.^[1] The depression trial enrols 240 participants with depressive disorder who are initiating a new antidepressant treatment after prior treatment failure.^[2]

What side effects are known?

The prescribing information for fluvoxamine maleate carries a boxed warning about an increased risk of suicidal thinking and behaviour in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders.^[3][4] The same warning appears in the extended-release capsule prescribing information.^[4] The prescribing information also lists serotonin syndrome as a warning and precaution, and notes that fluvoxamine should not be used together with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping them.^[4]