Magazine article Drug Topics

FDA Approves New Drug for Schizophrenia

Magazine article Drug Topics

FDA Approves New Drug for Schizophrenia

Article excerpt

NEW DRUG

The Food & Drug Administration recently approved paliperidone (Invega, Janssen, L.P.), an atypical antipsychotic, for the treatment of schizophrenia, a disease that affects more than two million Americans. It is the first new treatment for schizophrenia to be approved since 2003.

The drug is a once-daily extended-release (ER) system designed to deliver paliperidone, the active metabolite of risperidone, through the OROS osmotic drug technology. The delivery system consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane that controls the rate at which water enters the tablet core, which in turn determines the rate of drug delivery. "The ER system allows for less peak-to-trough variability, and, from a clinical aspect, less variable levels mean more stable patients," stated Kristin Murphy, Pharm.D., CCP, a consultant pharmacist at a developmental center in New Jersey.

The short-term efficacy of paliperidone was established in three six-week fixed-dose trials involving 1,665 non-elderly patients who met the criteria for schizophrenia. Efficacy was evaluated using the Positive and Negative Syndrome Scale (PANSS), a validated multi-item inventory to evaluate positive and negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression. Efficacy was also evaluated using the Personal & Social Performance (PSP) scale, a validated clinician-rated scale that measures personal and social functioning. Paliperidone demonstrated a statistically significant improvement versus placebo on the PANSS and the PSP.

Treatment-emergent adverse events reported in 5% or more of patients treated with paliperidone and at least twice the placebo rate for at least one dose included akathisia and extrapyramidal symptoms. Discontinuation rates due to adverse events were 5% for both the paliperidone and placebo groups. As with other atypical antipsychotics, there is a black box warning regarding the increased risk of death in elderly patients with dementiarelated psychosis compared with placebo. Paliperidone causes a modest increase in the corrected QT interval (QTc) and should be avoided in patients with congenital long QT syndrome, history of cardiac arrhythmias, and in combination with other drugs that prolong QTc. …

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