Updated on 18 December 2013
Drawbridge initiates clinical trial for anaesthetic drug
Singapore: Australia-based Drawbridge Pharmaceuticals has commenced a phase 1C clinical trial of alphaxalone dissolved in sulfobutyl ether beta cyclodextrin, Phaxan.
The project is a randomized double blind, dose-finding study using a Bayesian design. The purpose of the trial is to compare the anaesthetic properties of Phaxan with propofol, which is the current standard for intravenous anaesthesia.
The trial will be conducted at the Jessie McPherson Private Hospital under the guidance of investigator, Dr John Monagle, director of Monash Anaesthesia and Pain Management, at Monash Health.
"The aim of the trial is to reintroduce into clinical practice an intravenous anaesthetic which we believe has a higher safety profile than the drugs in current clinical practice," said Professor Colin Goodchild, chief medical officer at Drawbridge Pharmaceuticals.
Twenty-four subjects will take part in the trial, with 12 subjects to receive, propofol and 12 to receive the study drug, Phaxan. Pain on injection, which is a common problem with propofol, the quality of the anaesthesia and effects on cardiovascular and respiratory systems will be observed and compared between the drug treatments.
"The trial will be the first time that Phaxan has been tested clinically in a critical care setting; if ultimately shown to be safe and efficacious in humans, it could provide an alternative new treatment option for patients requiring intravenous anaesthesia," said Dr Anthony Filippis, CEO, Drawbridge Pharmaceuticals.