Reports of Agranulocytosis Prompt Monitoring for Investigational Parkinson's Drug
Four cases were associated with agranulocytosis, 2 had no white blood cell counts available and 1 had a high white blood cell count.
Due to some cases of agranulocytosis, Acorda Therapeutics has decided to increase the frequency of blood cell count monitoring to weekly for participants taking part in its Phase 3 program of tozadenant.
Tozadenant, an oral adenosine A2a receptor antagonist, is being investigated as an adjunctive treatment to levodopa in Parkinson disease patients to reduce 'off' time. A successful Phase 2b trial has already been completed.
As well as increasing blood cell count frequency for enrolled patients, the Company has also paused any new enrollment in the long-term studies.
The 2b and Phase 3 trials combined have had 890 patients exposed to tozadenant, among these there have been 7 cases of sepsis, 5 of which were fatal.
Four cases were associated with agranulocytosis, 2 had no white blood cell counts available and 1 had a high white blood cell count. “We have taken these steps in the best interests of the safety of patients in the tozadenant studies, which is our top priority,” said Acorda CEO, Ron Cohen, MD.
The current trial is comparing 2 doses of tozadenant, 60mg and 120mg, and comparing them to placebo. Dependent on further input from the Data Safety Monitoring Board (DSMB) and the Food and Drug Administration (FDA), the Company stated that they intend on moving forward with the study and expect to report results in the first quarter of 2018.
Acorda provides update on Tozadenant development program [press release]. Ardsley, NY: Acorda. Published November 15, 2017. Accessed November 21, 2017.