An announcement was made by the Newron Pharmaceuticals which is based in Switzerland that they have delayed their phase II and III of the clinical trials of the even amide for the Schizophrenia because of the security concerns which were raised by the United States’ Food and Drug Administration (FDA).
The concern was expressed by the agency over the outcomes of its recently completed studies on the dogs and rats which showed that the Central Nervous System (CNS) events which showed a chance of implication in the humans as well. United States’ Food and Drug Administration (FDA) asked the company to temporarily stop their launch of new research and studies until they get to finish further short term studies in the humans and rats in order to address the safety concerns.
The company is anticipating to have a meeting near in the future with the agency and then give the provision of further updates regarding the drug & plans for the trials. The Chief Medical Officer of the Newron Pharma, Ravid Anand passed the following statement: “ Based on the concerns that the United States’ Food and Drug Administration have raised by their letter, Newron is very confident that these issues can be addressed in a satisfactory manner.”
The other compounds of the company’s pipeline are inclusive of the Safinamide also known as Xadago which has been made available to the market since a decade in the Switzerland, United States as well as the European Union as a supplementary therapy in the Parkinson’s disease. In addition to this, it is also doing investigation on the sarizotan for the Rett syndrome as well as ralfinamide for the neuropathic pain. Sarizotan is more likely to get approved from the senior authorities.