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.

advertisement

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.

Leave a Comment

Please enter your name.
Please enter a comment.

  • Multiple back surgeries combined with the physical aspects of my job and VIOXX taken when I could no longer move was a miracle. I do not & won’t take opioids and would gladly take the risk of heart attack/stroke just for the pure relief VIOXX offers. I would gladly volunteer for a trial but I am not a hemophiliac and God Bless those who suffer even more than I do. I would gladly travel out of country to smuggle a private supply in for myself.

  • I cried when they took it off the market it helped me so much. Even my husband who hates medication begged for it. It helped us so much with our pain. Please let me know when it is available I would do a trail also

  • Vioxx was the only thing the could control my arthritis pain. 75 years old and about to give up, but I must keep fighting. Please bring back the the thing that helped me. Please keep in informed if it becomes available. Willing to be used as a Guinea pig.

  • I’d LOVE to get vioxx again! I’ve had 4 neck & 1 back surgery since 06 & I’d love to get off pain meds that basically run my life! Now with so many Idiots dying from Illegally using drugs I get less!!! I’ve never used Illegal drugs or broke any laws but chronic pain patients like me R being punished! BS! I’d gladly sing a waiver 2 B allowed 2 use vioxx again!!

  • 1 day my aunt who has lost all her toes & has terrible arthritis told me in order 4 vioxx 2 work it had 2 B taken every day. Not 4 me! I took it whenever the pain in my arm got 2 severe!

  • The first time I took a single vioxx pill for my knee I woke in the morning and slid of the bed slowly (ready for my first walk to the bathroom where I would adjust to the everyday pain and stiffness). Well, walking hunched over I got halfway around the bed and noticed how much pain I had actually been in for years and years. I realized it wasn’t just my knee but many many joints that I now realized I had just become accustomed to for my body felt so good. I hadn’t felt that way in forever. I too only took them every other or every third day. It was fantastic. When they removed it from the market I tried Celebrex to no result. Please bring it back.

  • I should also say but now many years later after getting my rotator cuff fixed and fought two battles of cancer now my arthritis is so severe that nothing touches it and I would love to get back on VIOXX

  • I was a user of vioxx, I was one of those people that did not take it every day. I took it once every other day or two days. I hate taking pills. I had great relief from my pain and thought I could tackle my job every day at work in the factory ( rotator cuff) I crave for VIOXX to be brought back because it worked. I would take it again under the same name even with all its warnings! All medicine had warnings. Even plain baby aspirin. If you need me for a study under my local Doctors watch please count me in!

  • This drug was amazing to me. Completely eliminated my arthritis pain. Celebrex simply did not do what Vioxx did. Yes, please bring it back.

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy