GlaxoSmithKline may launch Vioxx alternative

As we had pointed out in a previous article on Vioxx recall blog that many Merck competitors are rushing to the market with alternatives to Vioxx, we have now learned today that a major player wants to launch a new drug as an alternative to Vioxx (Related article: Alternatives to Vioxx emerging rapidly). As many readers know, Vioxx belongs to a category called Cox-2 inhibitors. Cox-2 inhibitors are mostly prescribed for arthritis pain, which affects an estimated 49 million people in the U.S., the world's largest drug market, according to the Centers for Disease Control and Prevention. Vioxx generated $2.5 billion in sales last year. Pfizer's Celebrex, a competitive product, had sales of $1.9 billion in 2003.

GlaxoSmithKline Plc, Europe's biggest drugmaker, says that its dual-acting Cox-2 inhibitor shows strong efficacy for the treatment of pain. 406381, a new dual -acting Cox-2 inhibitor, is active in pre-clinical models in both inflammatory and neuropathic pain. In Phase II studies for rheumatoid arthritis and osteoarthritis, the company says, ‘381 had better efficacy in the treatment of pain than placebo. In some pre-determined endpoints involving head-to-head comparisons, ‘381 was more effective than celecoxib, the current market leader. An initial study in neuropathic pain also suggested efficacy in this difficult-to-treat condition. In these Phase II studies, the adverse event profile was similar to celecoxib, and the overall safety evaluation supports progression to larger studies of longer duration.

The company will meet with regulatory agencies over the next few months to finalize Phase III development plans, and will then have better information on which to project a filing date for the product. GSK believes ‘381 has the potential to become a class-leading medicine for the treatment of pain.

Recommended link: Complete coverage of Vioxx recall