RELPAX (eletriptan hydrobromide) · UPJOHN
RELPAX (eletriptan hydrobromide) is a serotonin (5-HT 1B/1D) receptor agonist indicated for the acute treatment of migraine with or without aura in adults. The medication is intended for use only after a clear diagnosis of migraine has been established and is not indicated for the preventive treatment of migraines or for cluster headaches. If a patient does not respond to the initial treatment, the diagnosis should be reconsidered before further administration.
How RELPAX Works
RELPAX functions as an agonist at 5-HT 1B/1D receptors located on intracranial blood vessels and sensory nerves within the trigeminal system. By activating these receptors, the drug promotes the constriction of cranial vessels and inhibits the release of pro-inflammatory neuropeptides. These actions counteract the local cranial vasodilation and neuropeptide release thought to be responsible for migraine symptoms.
Details
- Status
- Prescription
- First Approved
- 2002-12-26
- Routes
- ORAL
- Dosage Forms
- TABLET
RELPAX Approval History
What RELPAX Treats
1 indicationsRELPAX is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
RELPAX Competitive Set
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Direct competitors
Same target(s) AND same indication — head-to-head.
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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Active Pipeline
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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.
RELPAX FDA Label Details
Indications & Usage
FDA Label (PDF)RELPAX is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: • Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with RELPAX, reconsider the diagnosis of migraine before RELPAX is administered to treat any subsequent attacks. • RELPAX is not intended for the prevention of migraine attacks. • Safety and effectiveness of RELPAX have not been established for cluster headache. RELPAX is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.