Elyxyb™ (celecoxib oral solution) is now available for the acute treatment of migraine with or without aura in adults.
Elyxyb is a ready-to-use oral solution formulation of celecoxib, a nonsteroidal anti-inflammatory drug (NSAID). It is formulated using a self-microemulsifying drug delivery system that improves solubility and bioavailability leading to faster absorption. Following administration of 120mg of Elyxyb under fasting conditions, the median time to peak concentration (Tmax) was observed to be 1 hour (range, 0.67-3.00).
The approval was based on data from 2 double-blind, placebo-controlled trials (ClinicalTrials.gov Identifier: NCT03009019, NCT03006276) that included patients with a history of episodic migraine (2 to 8 migraine attacks per month, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks). Results from both studies showed that a significantly greater proportion of patients treated with Elyxyb achieved pain freedom and most bothersome symptom freedom at 2 hours postdose compared with those treated with placebo.
The most common adverse reaction reported with Elyxyb was dysgeusia. Like other NSAIDs, Elyxyb carries a Boxed Warning related to the risk of serious cardiovascular and gastrointestinal adverse events.
Elyxyb is supplied as an oral solution containing 25mg of celecoxib per mL (120mg/4.8mL) in disposable glass bottles. The maximum dosage in a 24-hour period is 120mg. For patients who are prescribed the recommended dosage of 120mg, the entire amount of Elyxyb may be consumed directly from the bottle.
To provide support and resources to both health care providers and patients, the Company is launching the Elyxyb Passport Program, which includes a copay savings program.
- BioDelivery Sciences International announces Elyxyb™ is now available in the US for the acute treatment of migraine. News release. BioDelivery Sciences International, Inc. Accessed February 24, 2022. https://www.globenewswire.com/news-release/2022/02/24/2391451/0/en/BioDelivery-Sciences-International-Announces-ELYXYB-is-Now-Available-in-the-U-S-for-the-Acute-Treatment-of-Migraine.html.
- Elyxyb. Package insert. BioDelivery Sciences International, Inc.; 2022. Accessed February 24, 2022. https://www.elyxyb.com/images/global/elyxyb-prescribing-info.pdf.