FLECTOR (diclofenac epolamine)
Flector is a topical nonsteroidal anti-inflammatory drug (NSAID) that helps patients with acute pain resulting from minor physical injuries. It is used for adults and children aged 6 and older who have suffered strains, sprains, or contusions. This medication provides a localized way to manage the discomfort and inflammation associated with these types of trauma.
How FLECTOR Works
This drug works by inhibiting the enzymes COX-1 and COX-2, which are involved in the production of prostaglandins. Because prostaglandins sensitize nerves to pain and mediate inflammation, reducing their levels in peripheral tissues helps relieve pain and swelling.
Details
- Status
- Prescription
- First Approved
- 2007-01-31
- Routes
- TOPICAL
- Dosage Forms
- SYSTEM
FLECTOR Approval History
What FLECTOR Treats
4 indicationsFLECTOR is approved for 4 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
- Strains
- Sprains
- Contusions
FLECTOR Boxed Warning
RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use ( 5.1 ) FLECTOR is contraindicated in the setting of cor...
WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use ( 5.1 ) FLECTOR is contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.1 ) NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ( 5.2 ) Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [ see Warnings and Precautions (5.1) ]. FLECTOR is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications (4) and Warnings and Precautions (5.1) ] . Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [ see Warnings and Precautions (5.2) ].
FLECTOR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02324270 results posted | DICLO-13-01 | Ph 3 | completed | Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FLECTOR FDA Label Details
Indications & Usage
FDA Label (PDF)FLECTOR is indicated for the treatment of Pain; Strains; Sprains; Contusions.
WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombo...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.