Editor’s Note: A previous version of this story was accidentally published with incorrect information pertaining to an FDA approval. The FDA has not approved this as of Wednesday at 5:42 p.m..
Pozen stock rallied throughout the day Wednesday on expectations that the U.S. Food and Drug Administration would approve the company’s proposed migraine drug, Trexima.
A decision from the FDA may come nearly two months after Pozen disclosed two trials demonstrating the efficacy of Trexima.
Pozen (NASDAQ: POZN) stock closed up 80 cents, at $17.45 per share.
Trexima combines 85 milligrams of sumatriptan and 500 mg of naproxen.
The FDA rejected Trexima in June 2006, expressing concerns about possible side effefcts.
The news ignited a crash in Pozen shares, which collapsed to $5.26 from $13.90.
According to the American Medical Association, migraines affect an estimated 28 million people.
GlaxoSmithKline is partnering with Pozen in Trexima’s development. GSK has paid Pozen more than $35 million thus far to develop the drug.
Pozen used its proprietary technology to combine an existing GSK migraine drug Imitrex with naproxen, a non-sterodial anti-inflammatory drug.
The most recent trials showed Trexima was “nearly twice as effective as placebo” and also “eliminated all traditional migraine symptoms” at two hours and four hours after patients took one table. Symptoms include nausea, vomiting and light sensitivity.
"I believe this key endpoint will have more meaning to patients, as it measures when the whole migraine is gone rather than just the head pain," said Paul Winner, lead author and director of the Palm Beach Headache Center, in a statement released by Pozen. "In these studies, we found Trexima consistently eliminated migraine symptoms in more patients without the need for rescue medication."
Pozen also announced positive test results in April.
