BFAD approves schizophrenia treatment

It is estimated that one person in every 100 develops schizophrenia worldwide, one of the most serious types of mental illness. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as disorganized thinking and disorders of cognition.

The BFAD recently approved paliperidone extended release tablets, a new atypical antipsychotic medication, for the treatment of schizophrenia including acute and maintenance treatment for recurrence prevention.

Marketed by Janssen Pharmaceutica Philippines, a Johnson & Johnson company based in Parañaque City, the medication was specifically designed to deliver the active ingredient paliperidone through the unique osmotic-controlled release oral delivery system (OROS).

Launched recently in Cebu City during the 34th Annual Convention of the Philippine Psychiatric Association (PPA), paliperidone was approved based on the results of an extensive clinical development program enrolling more than 1,600 patients in three pivotal studies in the United States and other countries around the world. "We are pleased that innovative technologies in drug delivery are being applied to new treatments for schizophrenia," says Dr. Felicitas A. Soriano, PPA president.

Dr. Bernardo Conde, PPA past president said that clinical trials have proven that for many patients it significantly reduces the symptoms of schizophrenia, including improvement in patient functioning as measured by the personal and social performance scale.

The primary measure of efficacy in the pivotal trials was the positive and negative syndrome scale (PANSS), a tool commonly used in schizophrenia. Patient functioning and other measures of efficacy and tolerability were also included in these trials supporting approval of paliperidone in doses ranging from 3 to 12mg.

In a pooled analysis of the three pivotal trials, all doses of the medication demonstrated significant improvements in mean total score and in each of the five sub-scores of the PANSS versus placebo. Many patients on paliperidone experienced significant symptom improvement versus placebo as early as day four, which was maintained throughout the remainder of the study. In the clinical trials, the drug was found to be well-tolerated with a safety profile similar to placebo, including extrapyramidal side effect (EPS) rates, weight gain, and lipid level changes.

All doses of the drug demonstrated significant improvements in patient functioning versus placebo as measured by the personal and social performance (PSP) scale. The PSP scale is a validated, clinician-rated scale that measures personal and social functioning in four domains of behavior: socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors.

Paliperidone is made available by prescription and should be used only upon the advice and supervision of a physician.