Elyxyb FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 27, 2020.
Elyxyb (celecoxib) is an oral solution formulation of the nonsteroidal anti-inflammatory drug celecoxib (first approved under the brand name Celebrex) indicated for the acute treatment of migraine with or without aura in adults.
- Elyxyb oral solution contains celecoxib 120 mg/4.8 mL (25 mg/mL).
- Elyxyb is formulated using a self-micro emulsifying drug delivery system designed to improve the solubility and bioavailability of celecoxib, leading to better absorption. In clinical studies, Elyxyb demonstrated a rapid onset of action, which is critically important to patients suffering from acute migraine attacks.
- The recommended dose of Elyxyb is 120 mg taken orally, with or without food. The maximum dosage in a 24-hour period is 120 mg. Elyxyb should be used for the fewest number of days per month, as needed.
- The Elyxyb product label carries a boxed warning advising the risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke) and serious gastrointestinal adverse events (including bleeding, ulceration, and perforation of the stomach or intestines) which can be fatal.
- The most common adverse reaction (at least 3% and greater than placebo) is dysgeusia (altered sense of taste).
Development Timeline for Elyxyb
|May 5, 2020||Approval FDA Approves Elyxyb (celecoxib) Oral Solution For Acute Treatment Of Migraine With Or Without Aura In Adults|
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