Pfizer forced to halt pain drug trials

Pfizer has been told by the FDA to suspend trials of its novel injectable biotherapeutic tanezumab for chronic low back pain and painful diabetic peripheral neuropathy.

The US regulator’s request follows its consideration of reports of adverse events in osteoarthritis patients taking tanezumab, and concerns regarding the potential for such events in other patient populations in which the compound is being studied.

Pfizer previously halted trials of tanezumab in patients with osteoarthritis on 23 June.

For studies on clinical hold, recruitment of new patients and the dosing of existing patients are suspended.

Pfizer will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab.

Investigation of the compound will continue in some areas of unmet medical need, including cancer pain and pancreatitis, interstitial cystitis (painful bladder syndrome).

The news will be a blow to the US giant as pain medications were one of its six key ‘Invest to Win’ therapy areas announced in January.

Pfizer already markets Lyrica for neuropathic pain, and last year the drug was its second biggest seller, earning sales of $2.8 billion.

Ben Adams