The combination drug, known as Trexima, contains the treatments Imitrex and naproxen sodium, and is being developed by GlaxoSmithKline and Pozen.
“Recent research suggests that migraine is more complex than previously believed, consisting of multiple mechanisms that each contribute to migraine pain in different ways,” said lead author Jan Lewis Brandes, assistant clinical professor at Vanderbilt University School of Medicine.
“These studies found that Trexima, which is the first migraine-specific product designed to treat both inflammation and vasodilation in a single tablet, provided superior efficacy compared to placebo and its individual components.”
These studies were included in the new drug application currently under review by the FDA.
Imitrex is a prescription medication indicated for the acute treatment of migraine in adults. Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) and is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis. It is also indicated for the treatment of tendonitis, bursitis, acute gout and for the management of pain and primary dysmenorrhea.