Regulatory Focus™ > News Articles > FDA Panel Recommends Restarting Testing of Controversial Pain Drugs

FDA Panel Recommends Restarting Testing of Controversial Pain Drugs

Posted 13 March 2012 | By Alexander Gaffney, RAC 

An US Food and Drug Administration (FDA) Advisory Committee Panel recommended clinical trials testing anti-nerve growth factor inhibitors (anti-NGF inhibitors) be allowed to continue, with certain precautions, reports The Associated Press.

The Arthritis Advisory Committee (AAC) voted 21-0 on 12 March to recommend that research continue in light of the unmet needs of patients. Panelists noted many patients do not respond to existing pain medications such as aspirin and non-steroidal anti-inflammatory drugs.

The AAC said patients must be warned of the safety concerns of the anti-NGF inhibitors before resuming clinical trials participation, and must sign an informed consent waiver. Clinical trials sponsors will also be responsible for making sure patients do not suffer bone or joint damage throughout the trial.

FDA is not bound to the decisions of its advisory committees, but tends to agree with their assessments.

Read more:

USA Today - FDA panel supports continued testing of pain drugs

AAC - March 12, 2012: Arthritis Advisory Committee Meeting Announcement

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