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document
Exploring the role of tanezumab as a novel treatment for the relief of neuropathic pain . OBJECTIVE Evaluate efficacy and safety of tanezumab , a humanized monoclonal antibody against nerve growth factor , in neuropathic pain . DESIGN Two randomized controlled trials . SUBJECTS Patients with pain due to diabetic peripheral neuropathy ( DPN ) or postherpetic neuralgia ( PHN ) . METHODS In the DPN study , patients received subcutaneous tanezumab 20 mg or placebo on Day 1 and Week 8 . Evaluations included change from baseline in average DPN pain ( primary endpoint ) , Patient 's Global Assessment of DPN , and safety ( including neuropathy assessments ) . Due to a partial clinical hold limiting enrollment and treatment duration , the prespecified landmark analysis was modified post hoc from Week 16 to Week 8 . In the PHN study , patients received intravenous tanezumab 50 μg/kg , tanezumab 200 μg/kg , or placebo on Day 1 . Evaluations included change from baseline in average daily pain ( primary endpoint ) , Brief Pain Inventory-short form , Patient 's Global Assessment of pain from PHN , and safety . RESULTS Mean DPN pain reduction from baseline to Week 8 was greater with tanezumab vs placebo ( P = 0.009 ) ; differences in Patient 's Global Assessment of DPN were not significant ( P > 0.05 ) . Neither tanezumab dose resulted in significant differences vs placebo in efficacy in PHN ( P > 0.05 ) , although tanezumab 200 μg/kg provided some benefit . Neuropathy assessments showed no meaningful changes . CONCLUSIONS Tanezumab provided effective pain reduction in DPN . In PHN , only the highest tanezumab dose reduced pain ; treatment differences were not significant . No new safety concerns were observed despite preexisting neuropathy .
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Intervention_Pharmacological
tanezumab
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Intervention_Pharmacological
tanezumab
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Intervention_Pharmacological
tanezumab
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Intervention_Control
placebo
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Intervention_Pharmacological
tanezumab
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Outcome_Pain
Mean DPN pain reduction
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Outcome_Other
efficacy
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Participant_Condition
neuropathic pain .
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Participant_Condition
neuropathic pain .
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Participant_Condition
diabetic peripheral neuropathy ( DPN
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Participant_Condition
despite preexisting neuropathy