Paion candidate shows strong safety data

German biopharmaceutical company Paion has reported positive results from the first part of the Phase Ib study with short-acting intravenous  anesthetic/sedative CNS 7056, which further strengthen the safety  profile of the compound.

Following the successful proof-of-concept study reported in January  2009, the randomized, open, dose-escalation multiple-dose Phase Ib trial  further evaluates the sedation and recovery profile of CNS 7056. Before  commencing the second part of the study in volunteers undergoing a  standard colonoscopy procedure, the reversal of sedation induced with  CNS 7056 by the benzodiazepine antagonist, flumazenil, has been examined  in a double-blind design. In total, six volunteers received a high  single dose of CNS 7056 on two consecutive days. After successful  sedation, the subjects either received flumazenil or matching placebo on  day one and the alternative treatment on day two in a randomized manner.  The results reveal that a single dose of flumazenil is able to reverse  the effects of CNS 7056 within approximately 1.5 minutes in volunteers  with deep sedation/loss of consciousness. Subsequent re-sedation after  administration of flumazenil was not observed. The study is being  performed in the USA and is expected to complete before the end of  2009.