The company said Wednesday it would stop enrolling patients for two drug trials after observing seven cases of sepsis, five of which were fatal. Four of the sepsis cases were also linked to agranulocytosis, or a severe lack of white blood cells.
Acorda plans to monitor patients’ blood cell counts on a weekly basis once the trials resume, pending further conversations with the independent Data Safety Monitoring Board and the Food and Drug Administration.
“We have taken these steps in the best interests of the safety of patients in the tozadenant studies, which is our top priority,” said Ron Cohen, MD, Acorda’s president and CEO. “Contingent on further input from the DSMB and FDA, we continue to expect to report efficacy and safety results of the double-blind Phase 3 study in the first quarter of 2018.”
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