FDA Approves Celecoxib Oral Solution for Acute Migraine

By MD /alert Staff
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The FDA recently approved celecoxib oral solution 25mg/mL for adults with acute migraine with or without aura.

“[Celecoxib oral solution] 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, Sr. Vice President of the Proprietary Products Group, Dr.Reddy’s Laboratories, explained in a press release. “This allows for administration of a lower dose without affecting bioavailability.”

A study published in Headache in January found that celecoxib oral solution “was significantly more effective than placebo for the acute treatment of migraine, with a generally favorable tolerability and safety profile.” 

In that study, results showed that 35.6% of patients in the celecoxib oral solution group (98/275) reported freedom from pain at 2 hours post-dose, compared to 21.7% in the placebo group. Likewise, celecoxib oral solution reduced most burdensome symptom in 57.8% of patients compared to 44.8% in the placebo group.

“For patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options,” Namboodiripad concluded. “[Celecoxib oral solution]… makes it convenient for patients to take it immediately upon emergence of migraine attacks.”

The FDA label notes that celecoxib oral solution is not approved for prevention of migraine in adults.


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