Reuters reports the companies said in a combined release, "The agency has requested additional safety information on Trexima, which may require new studies." The agency admitted the drug was effective, but only issued a conditional approval pending the requested safety information.
The companies will meet with the FDA to come up with measures that could help the drug get full approval. Trexima is a combination of Imitrex and painkiller naproxen. If approved, the new drug would ease migraine headaches by allowing blood flow through the veins.
The release added that new studies on the drug would delay it for additional years. Glaxo had relied the new drug which it initially planned to launch in the third quarter of 2006 would succeed Imitrex, an older migraine drug.
