Sanofi's xaliproden effective against PSN

French pharmaceutical major Sanofi-Aventis says that results from a trial of its developmental analgesic xaliproden showed that the drug reduced the occurrence of peripheral sensory neuropathy in patients undergoing oxaliplatin-based chemotherapy. Trial data, which was announced during this year's Gastrointestianl Cancers Symposium, in San Francisco, USA, showed that xaliproden reduced PSN 39% without impacting the efficacy of the oxaliplatin regimen.

The study was run as a double-blind, placebo-controlled multicenter Phase III assessment of the drug's safety and efficacy in 649 patients with metastatic colorectal cancer who were taking FOLFOX4 (5-fluorouracil/leucovorin/oxaliplatin) chemotherapy. The two primary endpoints, reduction in PSN and non-inferiority of response to oxaliplatin, were achieved during the study.

Adverse reactions to xaliproden included diarrhea, insomnia, dizziness, anxiety, tinnitus and vertigo which, the researchers say, were in line with the side effects of other 5-HT1A agonist drugs currently on the market.