Linda A. Johnson, Related Press
Revealed 11:04 p.m. ET Nov. 22, 2017
Brad Sippy, Tremeau’s chief govt, developed a plan for nonopioid ache therapies.
(Photograph: Steven Senne / AP)
Trenton, N.J. – Might there be a second life for the once-popular arthritis tablet Vioxx? A startup pharmaceutical firm hopes so.
Merck & Co. voluntarily pulled the blockbuster drug in 2004 amid proof that it doubled the probabilities of having a coronary heart assault or stroke.
Now tiny Tremeau Prescription drugs is working to carry it again, to deal with extreme joint ache brought on by the bleeding dysfunction hemophilia. That’s for a lot fewer sufferers than the thousands and thousands who took Vioxx drugs for arthritis and different persistent ache — but when it’s accredited medical doctors might once more legally prescribe it to anybody.
Many hemophilia sufferers depend on opioid painkillers as a result of practically each different ache reliever will increase the danger of inside bleeding. Appreciable analysis exhibits Vioxx doesn’t do this.
“It appeared to me that there was an enormous unmet medical want” for these sufferers, Brad Sippy, Tremeau’s chief govt, informed The Related Press. He put collectively a plan and co-founded Tremeau final yr to develop nonopioid ache therapies for uncommon ailments.
A longtime pharmaceutical advertising and marketing govt, Sippy labored at Merck through the Vioxx period and helped with its recall from pharmacy cabinets. He additionally knew the ultimate patent defending Vioxx’s monopoly was expiring this fall.
When it stopped making Vioxx, Merck was going through hundreds of lawsuits from folks claiming the drug precipitated their coronary heart assaults or strokes. Merck’s personal analysis confirmed the drug doubled these dangers, however attorneys for sufferers claimed the corporate downplayed or hid that. Merck initially fought the lawsuits however in 2007 agreed to a $four.85 billion settlement.
If Tremeau will get approval in a number of years to start out promoting rofecoxib, the chemical identify for Vioxx, medical doctors might prescribe it to different folks with garden-variety persistent ache. Tremeau wouldn’t be capable of legally promote these unapproved makes use of, however some sufferers probably would need it. Vioxx was so efficient that some customers hoarded it after Merck took it off market.
“I do know lots of people who swore by Vioxx,” stated analyst Steve Brozak, president of WBB Securities. “Repurposing this for the hemophilia neighborhood is especially sensible.”
Dr. Steven Stanos, president of the American Academy of Ache Administration, an expert group for ache specialists, stated it made sense to attempt Vioxx for hemophilia joint ache.
“Vioxx was very potent,” he stated.
The drug would nonetheless carry a powerful warning about coronary heart assault and stroke dangers. Docs must stability its ache profit towards every affected person’s dangers, Stanos stated.
On Tuesday, Tremeau introduced that the Meals and Drug Administration not too long ago handed it an endorsement of types: an orphan drug designation. That’s for issues affecting fewer than 200,000 Individuals, and comes with advantages, together with tax credit on testing prices and a free FDA assessment.
Nonetheless, it’s no slam-dunk. Sippy stated the Cambridge, Massachusetts-based Tremeau should increase $25 million or extra to pay for testing in hemophilia sufferers. Then the outcomes have to be adequate for FDA approval.
Within the U.S., simply over 20,000 folks have hemophilia, an inherited dysfunction that leaves them with out key proteins within the blood wanted for clotting. The slightest damage can set off uncontrolled inside bleeding. For the reason that 1990s, most sufferers have been getting drugs that limits however doesn’t forestall all bleeding episodes. Blood buildup within the joints can injury them and trigger ache.
“With out different choices, opioids are sometimes the following step” after Tylenol, typically at excessive doses, stated Dr. Stacy Croteau of the Boston Hemophilia Heart, who’s a paid guide for Tremeau. “Rofecoxib would hopefully permit us to cut back use of opioids.”
In the meantime, Tremeau is deciding on the drug’s model identify. Sippy stated the Vioxx identify, now not protected by trademark, would possibly scare some folks, whereas others would keep in mind its effectiveness.
“We haven’t excluded it,” he stated.
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