While the markets reacted badly to the news Newron Pharmaceuticals SPA is to delay starting the pivotal program for its closely watched schizophrenia therapy evenamide, the Italian-headquartered drugmaker is confident that concerns raised by the US Food and Drug Administration over central nervous system events seen in animals can be allayed quickly.
Newron received a communication from the FDA indicating concern on findings from a recently completed toxicity study in rats as well as CNS events at higher doses in dogs, and the potential implication of these findings for patients