Oral Solution of Celecoxib Becoming Available for Acute Migraine Treatment 

Oral celecoxib (Elyxyb; BioDelivery Sciences International, Raleigh, NC and Dr. Reddy's Laboratories, Hyderabad, India) is a ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. This formulation of celecoxib is currently not available in the US and Canada, and it has now been announced that a formal launch will take place in 2022. 

The therapy is formulated using a self-micro-emulsifying drug delivery system that improves solubility and bioavailability of the drug. This allows for the administration of a lower dose to achieve therapeutic effect relative to a conventional oral solid dosage form.

“ELYXYB’s pivotal studies showed that the percentage of patients achieving Most Bothersome Symptom (MBS) freedom at 2 hours post-dose was significantly greater for those patients receiving ELYXYB versus those receiving placebo,” said Thomas Smith, MD, chief medical officer, BDSI. “Study 2 demonstrated that the percentage of patients reaching headache pain freedom 2 hours post-dose was significantly greater for those receiving ELYXYB versus those receiving placebo. The data also showed meaningful speed of onset with Tmax achieved in approximately 60 minutes.” 

Studies of oral celecoxib for treatment of headache in children are planned.