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Label indication Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) ( 1 ). 1.1 Obsessive-Compulsive Disorder Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. FDA label
Also known as Fluvoxamine maleate, SME3110, Luvox, Depromel
Fluvoxamine · 1 trial · 1 indication
The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD) in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum of three tablets twice a day. From weeks 7 to 10 participants received the same dose that was given during week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week. In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week. |
| Fluvoxamine | EXPERIMENTAL | In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given during week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week. In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week. |
| Name | Type | Description |
|---|---|---|
| Fluvoxamine maleate | DRUG | Film-coated tablet containing 25 mg of fluvoxamine maleate |
| Placebo | DRUG | Placebo tablet matching to fluvoxamine maleate |
Inclusion Criteria: 1. Subject has at least 16 points on Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score and at least 5 points in Obsession sub-total score and in Compulsion sub-total score respectively at the Screening period and Baseline. 2. Subject sh...
Fluvoxamine is a small molecule psychiatric drug being studied for the treatment of obsessive compulsive disorder. It is in Phase 3 clinical development for this indication. It belongs to the therapeutic area of psychiatry and is also known by the name fluvoxamine maleate.
Fluvoxamine targets SLC6A4, the serotonin transporter. It acts as an inhibitor of this target. By inhibiting SLC6A4, the drug affects serotonin signaling, which is the mechanism under investigation for obsessive compulsive disorder.
Fluvoxamine is developed by AbbVie Inc., which trades under the ticker ABBV. The company is the sponsor associated with the clinical development program for this asset in obsessive compulsive disorder.
Fluvoxamine is in Phase 3 clinical development for obsessive compulsive disorder. It is an investigational small molecule and is not described as approved. The Phase 3 program includes one completed trial, with no active trials currently listed.
Fluvoxamine has been studied in the Phase 3 trial NCT01933919, titled a Phase 3 study of fluvoxamine (SME3110) in pediatric and adolescent patients with obsessive compulsive disorder. That trial is completed, enrolled 38 participants, was randomized, double blind, and placebo controlled, and included patients aged 6 years and older.
Yes, fluvoxamine maleate is another name for fluvoxamine. The two names refer to the same drug asset, which is being developed by AbbVie Inc. under ticker ABBV for obsessive compulsive disorder and is currently in Phase 3 clinical development.