FDA OKs Celecoxib Oral Solution for Acute Migraine Treatment

Officials with the FDA have approved celecoxib oral solution 25 mg/mL (Elyxyb, Dr. Reddy’s Laboratories) for the acute treatment of migraine with or without aura in adults, according to a press release.¹

Celecoxib oral solution, previously known as DFN-15, is a selective inhibitor of cyclooxygenase-2, available in a ready-made liquid solution. It is not indicated for the preventive treatment of migraine.^1,2

Study results on the efficacy, tolerability, and safety of 120 mg celecoxib oral solution versus placebo for the acute treatment of migraine were published in Headache. For the trial, patients treated a single migraine attack with 120 mg celecoxib oral solution or placebo as soon as possible after onset of pain of moderate-to-severe intensity.²

A total of 622 patients were randomized to receive either 120 mg celecoxib oral solution or placebo and 567 patients treated a migraine with study drug. According to the data, at 2 hours postdose, celecoxib oral solution showed significant superiority to placebo for pain freedom (35.6% [98/275] versus 21.7% [57/263], P<.001), with an odds ratio (95% CI) of 2.00 (1.36, 2.94).²

Celecoxib oral solution was also significantly superior for freedom from most bothersome symptom (MBS) at 2 hours postdose (57.8% [134/232] versus 44.8% [104/232], P=.007), with an odds ratio (95% CI) of 1.68 (1.17, 2.43), according to the study.²

Overall, a total of 13.3% of patients treated with celecoxib oral solution reported a treatment-emergent adverse effect (TEAEs) and study drug-related TEAEs were reported by 9.1% of patients in the celecoxib oral solution group and 6% of placebo-treated patients. The most common TEAEs reported were dysgeusia and nausea.²

“Elyxyb is an oral solution of celecoxib formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption,” Anil Namboodiripad, PhD, senior vice president of the Proprietary Products Group, Dr. Reddy’s Laboratories, said in a statement.² “This allows for administration of a lower dose without affecting bioavailability. In pivotal studies, Elyxyb demonstrated a rapid onset of action which is critically important to patients suffering from acute migraine attacks.”

References:

1. Dr. Reddy’s Laboratories received approval for their NDA, ELYXYB (celecoxib oral soluton) 25 mg/mL, in the US. News Release. Dr. Reddy’s Laboratories; May 6, 2020. Accessed May 7, 2020. https://www.drreddys.com/media/904710/press-release_-elyxyb.pdf

2. Lipton RB, Munjal S, Brand-Schieber E, Tepper SJ, Dodick DW. Efficacy, tolerability, and safety of DFN-15 (celecoxib oral solution, 25 mh/mL) in the acute treatment of episodic migraine: a randomized, double-blind, placebo-controlled study. Headache. First published October 24, 2019. https://doi.org/10.1111/head.13663