The Phase 1 study will assess the safety and pharmacokinetic profiles of two different formulations of Fanapt in patients with schizophrenia.
Under an agreement signed in 2009 with Vanda Pharmaceuticals, Novartis has exclusive rights to the injectable formulation of Fanapt in the US and Canada.
Vanda has exclusive rights to the depot formulation outside the US and Canada, but Novartis has the option to enter into discussions with Vanda to co-commercialize Fanapt or receive sales royalties for such territory.
Vanda president and CEO Mihael Polymeropoulos said that an injectable formulation could offer a potential new option for patients with schizophrenia who might benefit from less frequent dosing compared to an oral medication.