Vanda Pharmaceuticals Announces Commencement of Clinical Study of Long-Acting Injectable Formulation of FanaptÃ‚®
ROCKVILLE, Md., April 11, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced today that Novartis Pharmaceuticals Corporation, an affiliate of Vanda's sublicensor Novartis Pharma AG, has initiated a clinical study to evaluate the long-acting injectable (or depot) formulation of Fanapt® (iloperidone). This is a Phase I study that will evaluate the safety and pharmacokinetic profiles of two different long-acting formulations of Fanapt® in patients with schizophrenia.
Under a 2009 agreement, Novartis has exclusive rights to the depot formulation of Fanapt® in the U.S. and Canada. Vanda has exclusive rights to the depot formulation outside the U.S. and Canada, but Novartis has the option to enter into discussions with Vanda to co-commercialize Fanapt® or receive sales royalties for such territory.
"We are very excited with the advance of the Fanapt® depot formulation into clinical studies," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. "A long-acting injectable formulation could offer a potential new option for patients with schizophrenia who might benefit from less frequent dosing compared to an oral medication."
Schizophrenia is a chronic, severe and disabling mental disorder, characterized by profound disruptions in thinking, affecting language, perception, and the sense of self. It often includes psychotic experiences, such as hearing voices or delusions. Schizophrenia typically begins in late adolescence or early adulthood and affects 2.4 million Americans or 1.1% of the U.S. adult population.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders. For more on Vanda, please visi