Elyxyb, an oral solution formulation of celecoxib (NSAID) by Dr. Reddy’s Laboratories has been approved recently on May 5, 2020 by the Food and Drug Administration (FDA), for the acute treatment of migraine with or without aura in adults.

The outcomes of two trials with patients having a history of episodic migraine (2- 8 migraine attacks/month, with 0-14 headache days/month, and 48 hours of headache-free period between attacks) confirmed this approval. The patients were randomized to obtain Elyxyb 120mg (in Study 1, 316 patients; in Study 2, 311 patients) or placebo (in Study 1, 315 patients; in Study 2, 311 patients). They were directed to treat a migraine with moderate to severe pain intensity. 

Pain freedom at 2 hours after the dose, along with most bothersome symptom (MBS) freedom (described as the lack of self-identified MBS like nausea, photophobia and phonophobia) were regarded as primary outcomes.

As a result, the number of patients achieving MBS freedom at 2 hours after the dose was considerably higher among Elyxyb-treated patients than placebo in both the studies. In Study 2, significantly higher patients after Elyxyb dose achieved headache pain freedom at 2 hours as compared to placebo. About 32.4% patients with Elyxyb dose were pain free at 2 hours as compared to 25.3% patients with placebo, as observed from study 1.

In terms of safety, dysgeusia was the most frequently reported adverse reaction. A Boxed Warning depicting severe gastrointestinal and cardiovascular adverse events risk associated with Elyxyb has been mentioned.

Elyxyb is available as a clear, colorless oral solution formulation with 25mg of celecoxib/mL (120mg/4.8mL). Maximum dose has been recommended as 120mg per day.

As per Anil Namboodiripad, Sr Vice President of the Proprietary Products Group, Dr. Reddy’s Laboratories, “Elyxyb offers better absorption due to its self-micro emulsifying drug delivery system that improves its solubility and bioavailability. It also has a rapid onset of action beneficial for patients suffering from acute migraine attacks.”