ROCKVILLE, Md., Jan. 11 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals today announced that Novartis Pharmaceuticals Corporation has launched Fanapt(TM) (iloperidone) in the U.S. Fanapt(TM) was approved by the U.S. Food and Drug Administration on May 6, 2009 for the acute treatment of schizophrenia in adults.
Vanda retains the right to commercialize Fanapt(TM) oral and depot formulations outside the U.S. and Canada. At Novartis’ option, the parties will enter into good faith discussions relating to an agreement for the co-commercialization of Fanapt(TM) outside of the U.S. and Canada or, alternatively, Novartis will receive a royalty based upon net sales.
About Fanapt(TM)
The FDA approval of Fanapt was supported by two placebo- and active-controlled short-term (4- and 6-week) trials and safety data derived from more than 2,000 patients. 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 across doses of 12 mg to 24 mg per day -- which is the recommended daily target dose range. Titration to the target dose of 12 mg per day can be achieved in 4 days.
Fanapt(TM) tablets are indicated for the acute treatment of schizophrenia in adults.
Serious Side Effects
Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect which could be fatal.
If you have diabetes or risk factors for diabetes (for example, obesity, family history of diabetes), or you have unexpected increases in thirst, urination, or hunger, your blood sugar should be monitored. Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking Fanapt and medicines like it.
Lightheadedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting or lying position (orthostatic hypotension) has been reported with Fanapt.
Fanapt can increase the level of the hormone prolactin. Tell your doctor if you have signs of high prolactin levels, such as breast enlargement, breast pain, or breast discharge.
Fanapt and medicines like it have been associated with swallowing problems (dysphagia). If you had or have swallowing problems, you should tell your doctor.
For males, in the rare event you have a painful or prolonged erection (priapism), lasting 4 or more hours, stop using Fanapt and seek immediate medical attention.
Common Side Effects
When taking Fanapt, you should avoid drinking alcohol, and you should not breastfeed.
About Vanda
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Vanda Pharmaceuticals Inc.
