SYDNEY - Australian biotechnology company Amrad Corporation Ltd. has started clinical trials of a reformulation of the fast-acting injectable anesthetic propofol, in preparation for registration of the drug in Europe next year.
Amrad spokesman Tony Radford said the company has started a bioequivalence study involving about 30 people in Germany that will compare the effects of the old and new formulation of propofol, marketed under the name Diprivan.
He said analysis of the clinical data will be completed by about November in preparation for registration of the drug in Europe next year. The product will be registered in the U.S. later.
Amrad said it is in discussions for marketing alliances with “a number of international pharmaceutical companies“ for the propofol reformulation, known internally as AM149. The patent rights to AM149 were licensed from RTP Pharma Inc., of Montreal.
AM149 has a number of advantages over the existing formulation, including a lower lipid concentration and improved bacterial resistance. The new formulation reduces the risk of postoperative infection due to accidental contamination. - Mark Lawson