The Food and Drug Administration (FDA) has approved Elyxyb (Dr. Reddy’s Laboratories), an oral solution formulation of celecoxib, for the acute treatment of migraine with or without aura in adults.
The approval of Elyxyb, a nonsteroidal anti-inflammatory drug (NSAID), was based on data from 2 double-blind, placebo-controlled trials involving 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 studies, patients were randomized to receive Elyxyb 120mg (Study 1: n=316; Study 2: n=311) or placebo (Study 1: 315; Study 2: n=311) and were instructed to treat a migraine with moderate to severe pain intensity.
The primary outcomes measures included pain freedom (defined as a reduction of moderate or severe headache pain to no pain) at 2 hours postdose, as well as most bothersome symptom (MBS) freedom (defined as the absence of self-identified MBS such as photophobia, phonophobia, and nausea).
Results showed that in both studies, the percentage of patients achieving MBS freedom at 2 hours postdose was significantly greater among Elyxyb-treated patients compared with those who received placebo (Study 1 % responders: 58.0% vs 44.4%, respectively [P =.003]; Study 2 % responders: 56.8% vs 43.9%, respectively [P =.006]).
In Study 2, the percentage of patients achieving headache pain freedom at 2 hours postdose was significantly greater among patients receiving Elyxyb, compared with those receiving placebo (35.1% vs 21.0%; P <.001). In Study 1, 32.4% of Elyxyb-treated patients were pain free at 2 hours postdose vs 25.3% of placebo-treated patients; while numerically greater, this was not found to be statistically significant (P =.076).
With regard to safety, the most common adverse reaction included dysgeusia. Like other NSAIDs, Elyxyb carries a Boxed Warning related to the risk of serious cardiovascular and gastrointestinal adverse events.
Elyxyb is supplied as a clear, colorless oral solution that contains 25mg of celecoxib per mL (120mg/4.8mL). The maximum dosage in a 24-hour period is 120mg.
“Elyxyb […] is formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption,” said Anil Namboodiripad, PhD, Sr Vice President of the Proprietary Products Group, Dr. Reddy’s Laboratories. “In pivotal studies, Elyxyb demonstrated a rapid onset of action which is critically important to patients suffering from acute migraine attacks.”
For more information visit fda.gov.