FDA puts brakes on experimental pain drug tests

-Johnson & Johnson and AstraZeneca announced in December that they have halted separate studies of experimental painkillers over concerns that a class of drugs once expected to generate as much as $11 billion in annual sales may raise the risk of joint damage.

NEW YORK ­– ­Johnson & Johnson and AstraZeneca announcedin December that they have halted  separatestudies of experimental painkillers over concerns that a class of drugs onceexpected to generate as much as $11 billion in annual sales may raise the riskof joint damage.
 
 
The class of painkillers known as anti-nerve-growth-factordrugs inhibits the production of nerve growth factor, which is believed tocontribute to pain.
 
One theory has been this type of drug masked pain so wellthat the drugs led to overactivity, causing wear and tear that triggered the damage and the need for joint replacements.
 
 
Meanwhile, Regeneron Pharmaceuticals Inc. of Tarrytown,N.Y., said the U.S. Food and Drug Administration had halted trials of itstreatment in the class known as anti-nerve growth factors.
 
 
The FDA said it was concerned that J&J's fulranumab andother drugs in the class may be associated with rapidly progressiveosteoarthritis, a wearing away of the cartilage protecting bone joints, orosteonecrosis, the death of bone tissue due to a lack of blood supply, JeffreyLeebaw, a spokesman for the New Brunswick, N.J.-based drugmaker told Reuters.
 
 
J&J isn't aware of trial results until researchersrelease data, so the company doesn't know how many side effects have occurred, ifany, he notes.
 
The company "will work with the FDA toward resolution ofthis issue," he says, adding that J&J didn't notify investors of thesuspension because it is "not a material event for us."
 
 
London-based AstraZeneca says it has voluntarily stoppedearly-stage research of a similar medicine, halting studies on MEDI-578, whichtreats nerve growth, to assess data on the product further.
 
 
"We saw a reason to put a halt to the studies to evaluatethe data and ascertain a sensible path forward," an AstraZeneca spokeswomansays in a statement.
 
 
Pfizer Inc., the world's largest drugmaker, suspended trialsof the pain drug tanezumab in June after reports that patients in one of itsstudies needed joint replacements. The move left nerve-growth inhibitors "atainted class" and has lowered investor's expectations, Ziad Bakri, a Cowen& Co. analyst in New York, told Bloomberg News.
 
Janet Milton-Edwards, a company spokeswoman, told BloombergNews that the suspension wasn't requested by regulators and the company hasn'tseen similar cases of bone-tissue death, she said. AstraZeneca is "evaluatinghow we will go forward" with the research, she said.
 
 
A Pfizer spokesman told Reuters that the company'sdevelopment program remains on hold. Pfizer is preparing a response to the FDAand is reviewing data from 15 studies of tanezumab, he said. 
 
Regeneron said in a regulatory filing that it and partnerSanofi-Aventis SA were told late last week by the U.S. Food and DrugAdministration that the drug, REGN475/SAR164877, was being placed on clinicalhold after a patient in another company's trial developed avascular necrosis ofa joint.
 
 
There are currently no ongoing trials with the Regenerondrug that are enrolling or treating patients, the company said in the filing.
 
Separately, Abbott Laboratories said its trial of ananti-nerve-growth-factor drug was proceeding as planned.



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