FDA Pauses Regeneron/Teva Painkiller Study

Opioid-alternative fasinumab gets halted during mid-stage trial due safety concerns.

Fasinumab study halted by FDA / Photo: FierceBiotech
Fasinumab study halted by FDA / Photo: FierceBiotech

An October 17th Reuters article reported the FDA has placed a hold on studies for a new pain-drug from Regeneron and Teva. The injectable painkiller, fasinumab, is designed to block nerve growth factor, but was linked to joint damage in a patient with advanced osteoarthritis during trials.

The two drug companies plan to seek the FDA’s blessing for a late-stage study on similar patients, excluding those with advanced osteoarthritis. The delay suggests fasinumab may be vulnerable to the same setbacks as other drugs in its class including heightened scrutiny, repeated delays, and labeling restrictions. Should fasinumab make it to market, it could be a highly lucrative alternative to prescription opioids without the high rates of addiction, overdose, and death.

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