Terumo Corp. will no longer develop the injectable surgical anesthetic TPM/Propofol for the Japanese market.
The Japanese healthcare equipment company ended its collaboration with Australia's Avecho Biotechnology Ltd. to develop a reformulation of the TPM/Propofol product.
Propofol is a general anesthetic used to induce and maintain sedation during surgery.
The vehicle used for the TPM/Propofol formulation was shown to be unsafe for a complete 24-hour infusion in previous toxicology studies, Avecho said. Due to this, the indication for the product would be restricted to the induction and short-term maintenance of anesthesia.
In a statement to Avecho, Terumo said it decided not to support further development of TPM/Propofol as safety concerns related to the length of infusion would be difficult to address with Japanese regulators.
"Given the size of the Japanese market, Terumo was unwilling to consider launching a propofol product with a restricted indication," Avecho said in a news release. Avecho added that it has yet to decide if it will continue to develop the existing TPM/Propofol formulation only for acute use or further optimize the formulation to resume the toxicology studies.