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.
I am not a hemophiliac. I suffer from extreme back and neck pain and all I needed to do is take 1 vioxx a week and all the pain was gone. I was literally totally pain free. Now I’m on 3 different opiods and I still hurt all the time. I pray you can bring vioxx back and widen it for people with extreme back pain. I will take the cardiac risk to actually be able to live life pain free and not chained to my couch or bed. You need someone to be in a trial I will gladly volunteer!!!!
Vioxx worked wonders for me. P,ease let me know if it comes back. I am in constant pain!
I would go back on Vioxx if they started to prescribe in a heart beat.
I had a hysterectomy back in 1991, there were complication, they had to do surgery again. During that surgery they nicked my sciatic nerve. I was in so much pain, my Dr prescribed Vioxx, I took until I couldn’t get any more
Some people don’t want to use marijuana. This drug worked wonders I am hoping they can bring it back.
I was prescribed Vioxx when I was 26 but refused it then and continued to treat my arthritis naturally.
Why are we using drugs such as Vioxx when we have marijuana?
It really doesn’t make any sense and the only argument (although there are many) needed to justify the legalization of marijuana is compare these two drugs.
Both relieve you of the pains and symptoms associated with arthritis.
But only one will kill you!
Cause marijuana doesnt help everyone and some of us dont want to smoke marijuana or cant because of our jobs.
I would go back on Vioxx in a minute.. I had 1 one 50 mg left today I could hardly move I finall cut it in half and my pain level is gone. Please Please let us buy it. I would be glad to sign a waiver. Life is not about quantity it’s about quality!
I only took 1 VIOXX one time for a shoulder injury. The results were amazing! Twenty minutes after taking the VIOXX I had zero pain in the shoulder and arm that I hadn’t been able to move for two day. Also full range of motion was retorted. Is VIOXX dangerous if is only used occasionally?
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