FDA Approves First Monthly Atypical Antipsychotic for Schizophrenia

antipsychoticsPatient compliance is one of the biggest obstacles to treating the mental disorder schizophrenia. A 2006 study published in the Journal of Clinical Psychiatry found that schizophrenia patients on atypical antipsychotics don’t take their meds for approximately one-third of the year. Another study found that 80 percent of schizophrenia patients relapse within five years.

A new once-monthly drug holds the potential to increase patient compliance. The U.S. Food and Drug Administration has approved Janssen Pharmaceuticals‘ Invega Sustenna for acute and maintenance treatment of schizophrenia. Invega Sustenna is the first extended-release, injectable atypical antipsychotic approved to treat schizophrenia in the U.S. Data from four acute-schizophrenia studies found that the drug improved patient symptoms compared to a placebo, while a longer-term maintenance study showed that Invega Sustenna significantly increased the time before a relapse occurred. Invega was previously approved in 2006 to treat schizophrenia. The drug is a relative of Risperdal, which lost patent protection in 2008. Janssen, based in Titusville, NJ, is owned by Johnson & Johnson.

While clinical studies have been promising, the drug does carry serious potential health risks: neuroleptic malignant syndrome (a life-threatening illness caused by a poor reaction to antipsychotic drugs), changes in heart rhythm, and tardive dyskinesia (a disorder similar to Tourette’s syndrome). Similar drugs have been associated with hormone changes, high blood pressure, diabetes, and decreased white blood cell count.

In related news, FDA advisers have backed Schering-Plough’s Saphris to treat acute schizophrenia. Other companies developing therapeutics for schizophrenia include Vanda Pharmaceuticals, whose atypical antipsychotic Fanapt was approved in May; Addex Pharmaceuticals, Cortex Pharmaceuticals, Titan Pharmaceuticals, and Curidium.

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