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 doubled 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 garden-variety chronic pain. Tremeau wouldn’t be able to legally promote those unapproved uses, but some patients likely would want it. Vioxx was so effective that some users hoarded it after Merck took it off market.

“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 Vioxx for hemophilia joint pain.

“Vioxx was very potent,” he said.

The drug would still carry a strong warning about heart attack and stroke risks. Doctors would have to balance its pain benefit against each patient’s risks, Stanos said.

On Tuesday, Tremeau announced that the Food and Drug Administration recently handed it an endorsement of sorts: an orphan drug designation. That’s for disorders affecting fewer than 200,000 Americans, and comes with benefits, including tax credits on testing costs and a free FDA review.

Still, it’s no slam-dunk. Sippy said the Cambridge, Mass.-based Tremeau must raise $25 million or more to pay for testing in hemophilia patients. Then the results must be good enough for FDA approval.

In the U.S., just over 20,000 people have hemophilia, an inherited disorder that leaves them without key proteins in the blood needed for clotting. The slightest injury can trigger uncontrolled internal bleeding. Since the 1990s, most patients have been getting medicine that limits but doesn’t prevent all bleeding episodes. Blood buildup in the joints can damage them and cause pain.

“Without other options, opioids are often the next step” after Tylenol, sometimes at high doses, said Dr. Stacy Croteau of the Boston Hemophilia Center, who is a paid consultant for Tremeau. “Rofecoxib would hopefully allow us to reduce use of opioids.”

Meanwhile, Tremeau is deciding on the drug’s brand name. Sippy said the Vioxx name, no longer protected by trademark, might scare some people, while others would remember its effectiveness.

“We haven’t excluded it,” he said.

  • Vioxx was a life saver for me.I have severe back pain. Just sitting hurts badly and sleeping. All I used to have to take was 1 vioxx a week and I was completely pain free. I would have continued taking it knowing the risks.My life went so down hill after they took it off the market.I’m in so much pain all the time I pray every day they bring vioxx back. If not I’ll be in a wheelchair soon. Vioxx made me have no pain. FDA doesn’t realize how important it is to put it back on the market!!!!!!!!

  • when I heard that viox was taken from the market, it made me sad. for me it work really well. just the other day I had pain like crazy I need viox.

  • I took vioxx because of surgery going bad and ending up with a nicked sciatic. My Dr, started me on vioxx to help with the pain. After a yearlong recovery, vioxx let me have not pain free life, but a controlled pain life. I can not take opioids for pain, ibuprofen or most drugs because of stomach issues. So I would be the first person to take vioxx when you put vioxx back on the market. Vioxx for me had no side effects, like other drugs, please bring it back. Thank you Mary Cox

  • I have severe chronic pain, fatigue fibromyalgia etc…and had to file for disability in 2013. After having gastric bypass surgery in 2002 I was prescribed Vioxx because I could no longer take prescription strength ibuprofen. This drug WORKED, and for me it was the only one in its category that gave reliable relief. I believe that ANYONE who takes, is prescribed, a medication should do their research and be responsible in knowing the risks of taking certain medications. And only then decide whether the risks outweigh the benefits. It seems to be easier to just blame someone else rather than accepting the risks. Like me, I’m sure there were SO many taking this medication responsibly fully well knowing, and accepting, the risks in doing so. Chronic pain is a relentless, merciless monster that takes away the ability to live your life instead of just trying to exist. And like me, I’m sure there were many who suffered when this drug was taken off the market because being able to live eclipsed ANY side effect this medication could cause. All medications, even OTC ones, can have serious side effects. So do your research, educate yourself and make a responsible decision on what is right for you. A decision that was taken away from so many patients who had life changing benefits from taking Vioxx.

  • Vioxx got a bad rap. People quit taking aspirin for pain (which thins blood) when they started taking Vioxx.
    The quality of life with Vioxx is worth the risk for me.
    I want my Vioxx back!

  • I was successfully using Vioxx when it was recalled. I was getting relief of joint pain.
    Four years later, I was prescribed opioids for pain. I became an opioid addict, at 63 years of age. I went through rehab , thirty days away from my home and family.
    Please work for me and others to be able to take Vioxx again. It relived my arthritis pain. I also now suffer with fibromyalgia. Please help me.

  • Vioxx simply worked whereas other NSAID products are of little to no use in treating my pain, no matter the dosage. I am at risk of stomach bleeding and other peoblems, and I still have pain. Please bring it back.

  • Vioxx was like a miracle drug for me. Pain FREE and no side effects. I felt NORMAL for the first time in years. I don’t know but I felt if taken responsibly, perhaps there wouldn’t have had the results that brought it down…much like Opiods for pain patients. It’s the abusers that seem to be the problem, leaving true pain patients scrambling for relief.

  • I got gout.vioxx wiped out most of the intense pain right off, by the next pill it was all gone. Love that drug!!

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