MAXALT
MAXALT (rizatriptan benzoate) is a serotonin (5-HT) 1B/1D receptor agonist indicated for the acute treatment of migraine with or without aura. The medication is approved for use in both adults and pediatric patients aged 6 to 17 years. It is intended for use only after a clear diagnosis of migraine has been established and is not indicated for the preventive therapy of migraine or the treatment of cluster headaches. Furthermore, the drug is not indicated for the management of hemiplegic or basilar migraine.
How MAXALT Works
Rizatriptan functions by binding with high affinity to human cloned 5-HT 1B/1D receptors. The drug's therapeutic effects are presumably exerted by binding to these receptors located on intracranial blood vessels and sensory nerves of the trigeminal system. By acting as an agonist at these specific serotonin receptor sites, the medication addresses the physiological pathways involved in an acute migraine attack.
Details
- Status
- Prescription
- First Approved
- 1998-06-29
- Routes
- ORAL
- Dosage Forms
- TABLET
MAXALT Approval History
What MAXALT Treats
1 indicationsMAXALT is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
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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.
MAXALT FDA Label Details
ProIndications & Usage
FDA Label (PDF)MAXALT ® and MAXALT-MLT ® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks. MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications ] . MAXALT is not indicated for the preventio...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.