Jazz Pharmaceuticals Approved For U.S. Marketing Of Versacloz For Schizophrenia

Jazz Pharmaceuticals announced via press release that the Food and Drug Administration (FDA) has approved Versacloz. The oral suspension of clozapine is the first and only liquid formulation approved for schizophrenia or schizoaffective disorder. The liquid preparation may be more tolerable to this patient population and may help health care providers in institutional settings prevent patients from hiding pills or giving medication to others. Bruce C. Cozadd, chairman and CEO at Jazz Pharmaceuticals said, "Versacloz is an important addition to our existing psychiatry product portfolio and offers physicians another treatment option to help patients with limited treatment options."

Schizophrenia

Schizophrenia is a brain condition whereby the patient experiences reality disturbances. Some hear voices, while others are paranoid. Some become comatose or unresponsive and yet others talk a lot and do not make sense. The condition is disabling and chronic. Patients cannot function properly in society, have trouble holding jobs, and often must depend on family care. Current medications offer symptom relief that helps patients lead more functional lives.

Versacloz

Versacloz is an antipsychotic medication for people who have not responded to other drugs or treatments. It treats recurrent suicidal thoughts and behaviors, as well. Versacloz is a liquid product with no taste. Patients can take it on an outpatient or inpatient basis. Due to risks with clozapine, patients can only obtain the drug through the Versacloz Patient Registry, which monitors blood cell counts. Jazz Pharmaceuticals promises to provide value to the psychiatric community by providing enhanced support and monitoring not provided by generic manufacturers of clozapine.

FDA Approval

The FDA based the approval on clozapine general studies. Previous studies have shown that patients taking clozapine showed improvement. They also experienced less suicidal behavior. The FDA has asked Jazz to conduct a post-approval study on tolerability and self-administration of the liquid product. In other words, the FDA wants to know if this population of people is able to take the drug efficiently.

About Jazz Pharmaceuticals 

Jazz Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a diverse portfolio. Areas of focus include psychiatry, pain, hematology/oncology, and narcolepsy. The company markets its products in the U.S. and abroad. Defitelio (defibrotide), for hepatic veno-occlusive disease (VOD), is launching in Europe in 2014. Drugs for sleep and oncology are in the pipeline.  

Source:

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