Merck & Co. (MRK) willingly pulled the blockbuster drug in the year 2004 amid evidence that it is doubled the chances of having a stroke or heart attack.
Now tiny Tremeau Pharmaceuticals is working on it to bring it back, to treat severe joint pain which caused by the bleeding disorder hemophilia. That is for far smaller amount of patients than the 1000 thousands who has taken Vioxx pills for arthritis and other kind chronic pain — but if it did approve doctors could again legally prescribe it to anybody.
Many hemophilia patients count on on opioid painkillers cause nearly every other pain remover increases the risk of internal bleeding. operative research shows Vioxx disease does not affect in that way.
It seemed me that there was a big unmet medical necessity- for these patients,Tremeau's chief executive ,Brad Sippy told The Associated Press. He put together a plan and co-founded Tremeau previous year to develop nonopioid pain treatments for very rare diseases.
A pharmaceutical marketing executive, Sippy worked at Merck while the Vioxx era and helped with its recall from pharmacy shelves. He also knew the final patient protecting Vioxx's monopoly was expiring this fall.
When it stopped making Vioxx, Merck was facing 1000s of lawsuits from people claiming the drug caused their strokes or heart attacks. Merck's own research showed the drug 2x those risks, but lawyers for patients promises the company concealed or downplayed that. Merck basically fought the lawsuits but in the year 2007 agreed to a 4.85b dollar settlement.
If Tremeau gets applause in a few years to start selling rofecoxib, the chemical name for Vioxx, doctors would prescribe it to other people with garden-variety chronic pain. Tremeau wouldn't be able to lawfully promote those unapproved uses, but some patients perhaps would want it. Vioxx was so feasible 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 in california. "Repurposing this for the hemophilia community is specially brilliant."
Dr. Steven Stanos who is president of the American Academy of Pain Management what is a professional group for pain specialists, they said it made sense to try Vioxx for hemophilia joint pain.
"Vioxx was very potent," he said.
The drug would still carry a strong threat about stroke and heart attack risks. Doctors would have to assuage its pain benefit against each patient's risks, Stanos said.
On Tuesday, Tremeau was claiming that the Food and Drug Administration recently handed it an indorsation of sorts: an orphan drug designation. That's for diseases affecting fewer than 200k Americans, and comes with benefits, including a free FDA review and tax credits on testing costs.
Still, it's no slam-dunk. Sippy said the Cambridge, Massachusetts-based Tremeau must raise 25 million dollar or more to pay for testing in hemophilia patients. Then the results should be good enough for FDA approval.
In the U.S., just over 20 thousands people have hemophilia, an inherited disorder that leaves them without key proteins in the blood needed for clotting. The short injury can cause insensitive internal bleeding. Since the 1990s, most patients have been getting medicine that limits but doesn't confine all bleeding episodes. Blood buildup in the joints can damage them and trigger pain.
"Without other opinions, opioids are often the next place" after Tylenol, sometimes at high doses, said Dr. Stacy Croteau, who has been 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.