SymBio suspends enrollment in Phase III of Ionsys

SymBio Pharmaceuticals Ltd. (JASDAQ:4582) suspended enrollment in a Japanese Phase III trial of SyB P-1501 to manage acute postoperative pain during hospitalization after partner The Medicines Co. (NASDAQ:MDCO) said it intended to divest the program. According to an SEC filing, The Medicines Co. will seek to partner or divest the product, and may discontinue commercialization if a deal is not found in 2Q17.

The double-blind, placebo-controlled trial is evaluating SyB P-1501 in about 312 patients. Patients can self-administer up to 6 doses of 40 µg of fentanyl every hour, with up to 80 doses daily for up to 3 days. The trial's primary endpoint is the proportion of dropouts due to inadequate analgesia between hours 3-24 of treatment period. The secondary endpoint is proportion of dropouts due to inadequate analgesia during the period between the start and hour 24 of system application...