Startup wants to bring back Vioxx

TRENTON, N.J. — Could there be a second life for the once-popular arthritis pill Vioxx? A startup pharmaceutical company hopes so.

Merck & Co. voluntarily pulled the blockbuster drug in 2004 amid evidence that it increased the chances of having a heart attack or stroke.

Now tiny Tremeau Pharmaceuticals is working to bring it back, to treat severe joint pain caused by the bleeding disorder hemophilia. That’s for far fewer patients than the millions who took Vioxx pills for arthritis and other chronic pain — but if it’s approved doctors could again legally prescribe it to anyone.

Many hemophilia patients rely on opioid painkillers, because nearly every other pain reliever increases the risk of internal bleeding. Considerable research shows Vioxx doesn’t do that.

“It seemed to me that there was a huge unmet medical need” for these patients, said Brad Sippy, Tremeau’s chief executive. He put together a plan and co-founded Tremeau last year to develop nonopioid pain treatments for rare diseases.

A longtime pharmaceutical marketing executive, Sippy worked at Merck during the Vioxx era and helped with its recall from pharmacy shelves. He also knew the final patent protecting Vioxx’s monopoly was expiring this fall.

When it stopped making Vioxx, Merck was facing thousands of lawsuits from people claiming the drug caused their heart attacks or strokes. Merck’s own research showed the drug doubled those risks, but lawyers for patients claimed the company downplayed or concealed that.

Merck initially fought the lawsuits but in 2007 agreed to a $4.85 billion settlement.

If Tremeau gets approval in a few years to start selling rofecoxib, the chemical name for Vioxx, doctors could prescribe it to other people with gardenvariety chronic pain. Tremeau wouldn’t be able to legally promote those unapproved uses, but some patients likely would want it.

“I know a lot of people who swore by Vioxx,” said analyst Steve Brozak, president of WBB Securities. “Repurposing this for the hemophilia community is particularly brilliant.”

Dr. Steven Stanos, president of the American Academy of Pain Management, a professional group for pain specialists, said it made sense to try