Vanda Pharmaceuticals Inc. announced that the US Patent and Trademark Office has issued a notice of allowance for its patent application of a microsphere, long-acting injectable formulation of its antipsychotic product, Fanapt (iloperidone). When issued, this US patent will expire on October 30, 2022, and in addition, the US Patent and Trademark Office has granted a patent term adjustment of 300 days, leading to an effective expiration date of August 26, 2023.
The oral formulation is marketed in the US under the tradename Fanapt by Novartis Pharmaceuticals Corporation pursuant to an agreement between Vanda and Novartis Pharma AG, which was entered into on October 12, 2009. Novartis is responsible for the commercialization and further clinical development activities of Fanapt in the US and Canada, including the development and commercialization of the long-acting injectable (or depot) formulation of Fanapt. Vanda retains rights to commercialize Fanapt oral and depot formulations outside the US and Canada.
Fanapt tablets are indicated for the acute treatment of schizophrenia in adults. Fanapt belongs to a class of medications for schizophrenia known as atypical antipsychotics.
The FDA approval of Fanapt was supported by two placebo- and active-controlled short-term (4- and 6-week) trials. Safety data was derived from more than 2,000 patients in short- and long-term studies. Both trials enrolled patients who met the DSM-III/IV criteria for schizophrenia. Fanapt was shown to be superior to placebo in controlling symptoms of schizophrenia using the Positive and Negative Symptom Scale (PANSS) and the Brief Psychiatric Rating Scale (BPRS). Efficacy was demonstrated across doses of 12 mg to 24 mg per day -- which is the recommended daily target dose range. Fanapt must be titrated slowly from a low starting dose to avoid orthostatic hypotension; titration to the lowest effective dose of 12 mg per day can be achieved in four days with the use of an available titration pack. Fanapt can be administered without regard to meals.
The effectiveness of Fanapt for more than 6 weeks has not been systematically evaluated in clinical trials. Therefore, the physician who elects to use Fanapt for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Novartis has exclusive commercialization rights to the oral formulation of Fanapt in the US and Canada under an agreement with Vanda Pharmaceuticals Inc., as well as exclusive rights to develop and commercialize a long-acting injectable (or "depot") formulation of this medicine for these markets.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders.