Scilex Holding Company has announced the relaunch of Elyxyb™ (celecoxib oral solution) for the treatment of acute 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).
Elyxyb was originally approved by the Food and Drug Administration (FDA) in May 2020 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). In both trials, a significantly greater proportion of patients treated with Elyxyb achieved pain freedom and most bothersome symptom freedom at 2 hours postdose compared with those who received 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 glass bottles and is now available in pharmacies. For patients who are prescribed the recommended dosage of 120mg, the entire amount of Elyxyb may be consumed directly from the bottle. The maximum dosage in a 24-hour period is 120mg.
Scilex Holding Company announces the commercial launch of Elyxyb™ (celecoxib oral solution) in the US, strengthening its leadership position in non-opioid pain management. News release. Scilex Holding Company. Accessed February 27, 2023. https://www.globenewswire.com/news-release/2023/02/27/2616161/0/en/Scilex-Holding-Company-announces-the-commercial-launch-of-ELYXYBTM-celecoxib-oral-solution-in-the-U-S-strengthening-its-leadership-position-in-non-opioid-pain-management.html.
This article originally appeared on MPR