Regulatory Focus™ > News Articles > US Regulators Reassessing Anti-NGF Pain Pills Linked to Joint Damage

US Regulators Reassessing Anti-NGF Pain Pills Linked to Joint Damage

Posted 12 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is reassessing whether or not manufacturers of anti-nerve growth factor (anti-NGF) pain pills should be allowed to proceed with clinical trials after a two year hold on existing clinical trials, reports Reuters.

The trials were stopped in 2010 after hundreds of clinical trials participants required joint replacement surgery after taking the drugs, though testing was allowed to continue for terminally ill cancer patients.

Pfizer, Regeneron Pharmaceuticals and Johnson & Johnson are all arguing to resume trials on the products-assumed to be a multi-billion dollar per year market-based on the unmet need in the chronic pain market.

In a statement, FDA said the drugs "represent a potentially significant and novel strategy" for treating pain, but it needed to weigh the benefits of the drug against its "usually severe" risks.

The discussion now moves before an FDA advisory committee panel for discussion and consideration on 12 March.

Read more:

Reuters - FDA asks experts if pain drugs get second chance

Medical Daily - Federal Regulators to Decide the Fate of Experimental Drugs Linked to Bone Decay, Joint Failure

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