Feb 11 2014
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced U.S. commercial availability of Versacloz™ (clozapine, USP) oral suspension, the first and only oral suspension clozapine for severely ill treatment-resistant schizophrenia patients or those at risk of recurrent suicidal behavior with schizophrenia or schizoaffective disorder.
"We are pleased to offer patients with treatment-resistant schizophrenia a new liquid formulation of clozapine that is FDA approved to treat this difficult condition," said Bruce C. Cozadd, chairman and CEO at Jazz Pharmaceuticals plc. "Versacloz is an important addition to our existing psychiatry product portfolio and offers physicians another treatment option to help patients with limited treatment options."
Versacloz is an atypical antipsychotic indicated for the treatment of people with schizophrenia who have failed to respond adequately to other therapies. Versacloz is also approved to reduce the risk of recurrent suicidal behavior in people with schizophrenia or schizoaffective disorder who are at chronic risk for re-experiencing suicidal behavior. Versacloz has a unique, tasteless formulation and can be administered in an outpatient setting or under the supervision of a healthcare professional through an oral suspension. This formulation helps eliminate the mixing and matching of pill dosage strengths. In institutional settings, the formulation may help with confirmation of administration, and may reduce the possibility of "cheeking," hiding, or sharing the medication.
Because of the risk of agranulocytosis with clozapine therapy, Versacloz will be available only through a restricted program called the Versacloz Patient Registry, which ensures appropriate monitoring of white blood cell and absolute neutrophil count prior to delivery of the next refill of medication.1 As part of its ongoing commitment to the psychiatry community, Jazz Pharmaceuticals, through the Versacloz Patient Registry and experienced Clinical Compliance Liaisons, will provide blood monitoring and reporting support services not typically offered by generic clozapine manufacturers.
"In my experience, some treatment-resistant schizophrenia patients may cycle through four or five typical and atypical antipsychotic treatments while failing to maintain adequate symptom control," said Gustavo Alva, MD, DFAPA, Medical Director at ATP Clinical Research. "When patients reach this stage, the next move matters – now with oral suspension Versacloz, we have another option to help patients."
The Food and Drug Administration (FDA) approval of Versacloz was based on general studies related to clozapine. Efficacy in treatment-resistant schizophrenia was established in a six-week active-controlled study in patients who had failed other antipsychotics. Efficacy in reducing recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder was demonstrated over a two-year treatment period in the InterSePT™ trial. As part of the New Drug Application filing for Versacloz, the FDA required a post-approval usability study to determine a patient's ability to self-administer the oral suspension.
Versacloz is distributed by Jazz Pharmaceuticals, Inc., a U.S. subsidiary of Jazz Pharmaceuticals plc.