Vanda Pharmaceuticals and Novartis Pharmaceuticals, 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.
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."