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A randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ABT-594 in patients with diabetic peripheral neuropathic pain.

Author(s): Rowbotham MC, Rachel Duan W, Thomas J, Nothaft W, Backonja MM

Affiliation(s): UCSF Pain Clinical Research Center, University of California, San Francisco, CA, USA.

Publication date & source: 2009-07-23, Pain., [Epub ahead of print]

ABT-594 is a neuronal nicotinic acetylcholine receptor (NNR) agonist that exhibits potent analgesic activity in preclinical models of acute, chronic, and neuropathic pain. The purpose of this phase 2, randomized, multicenter, double-blind, placebo-controlled study was to evaluate the safety and analgesic efficacy of ABT-594 in patients with diabetic peripheral neuropathic pain (DPNP). A total of 266 DPNP patients were randomized 1:1:1:1 to receive placebo, ABT-594 150mug BID, ABT-594 225mug BID, or ABT-594 300mug BID. Patients were titrated to a fixed-dose of ABT-594 over 7days and remained at this dose for another 6weeks. Compared to placebo, all three ABT-594 treatment groups showed significantly greater decreases on the average diary-based 0-10 Pain Rating Scale (PRS) score from baseline to final evaluation, the primary efficacy measure (placebo, -1.1; 150mug BID, -1.9; 225mug BID, -1.9; 300mug BID, -2.0). The proportion of patients achieving at least a 50% improvement in the average diary-based PRS was greater in all three ABT-594 treatment groups. However, adverse event (AE) dropout rates were significantly higher in all three ABT-594 treatment groups (28% for 150mug BID, 46% for 225mug BID, and 66% for 300mug BID) than for the placebo group (9%). Consistent with the expected side-effect profile of NNR agonists, the most frequently reported AEs were nausea, dizziness, vomiting, abnormal dreams, and asthenia. This study establishes proof of concept for NNR agonists as a new class of compounds for treating neuropathic pain.

Page last updated: 2009-10-20

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