Mixed results for Sanofi-Aventis: insomnia study good, antidepressant faces setback

French drug major Sanofi-Aventis has reported data from ongoing trials for three of its pipeline candidates. The GEMS and NOCTURNE studies on  insomnia drugs eplivanserin and volinanserin, respectively, have shown  positive outcomes, whereas the INDIGO study, investigating the safety  and efficacy of antidepressant saredutant on the elderly, did not reach  significance versus placebo. Lastly, the firm said the final results of  the ATHENA study on Multaq (dronedarone) would be presented later this  month.

The GEMS study was a Phase III randomized, double-blind,  placebo-controlled, parrallel assignment trial on 948 patients with  insomnia, characterized by sleep maintenance difficulties or night-time  awakenings. The primary endpoint of the trial was to assess the sleep  drug's efficacy vs placebo after six and 12 weeks using the functional  outcome of sleep questionnaire (FOSQ). Secondary endpoints included:  evaluating patients' daytime function; identifying any residual  effects; noting any effect on sleep following abrupt discontinuation of  treatment after 12 weeks; and building a profile on the candidate's  safety and tolerability.

The trial showed eplivanserin significantly reduces wake time after  sleep onset and the number of night-time awakenings reported by the  patient after six and 12 weeks vs placebo. The drug also showed good  safety and tolerance vs placebo, with no adverse effects, rebound  phenomenon or withdrawal symptoms. This is the final Phase III trial  required after the success of the previous EPLILONG and EPOCH studies,  and Sanofi intends to file an application in the second half of 2008.