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Acorda Therapeutics said today it has paused enrollment of new patients in its Phase III studies assessing its Parkinson’s disease candidate tozadenant after seven patients treated with the drug developed sepsis—five of whom died. The enrollment pause will continue pending further talks with the studies’ independent Data Safety Monitoring Board (DSMB) and the FDA, Acorda said. “Contingent on further input from the DSMB and FDA, we continue to expect to report efficacy and safety results of the double-blind Phase III study in the first quarter of 2018,” Acorda President and CEO Ron Cohen, M.D., said in a statement. Four of the sepsis cases were associated with agranulocytosis, two had no white blood cell counts available at the time of the event and one had a high white blood cell count, the company disclosed, without saying how many of the agranulocytosis-associated sepsis cases resulted in death. ...NEXT ARTICLE
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Parkinson's is a progressive neurological condition, affecting one person in every 500, 95% of which are over 40. It is caused by degeneration of more than 70% of the substantia nigra, which depletes the dopamine (the neurotransmitter involved in pro...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...