FDA Approves Monthly Antipsychotic Drug

The FDA approved the first monthly atypical antipsychotic drug for schizophrenia Wednesday, which doctors hope will help patients take medication on a regular basis. Paliperidone palmitate (Invega Sustenna) is approved for both acute and maintenance treatment.

Approval of the new drug was based on four clinical trials of acute symptom control that improved patient symptoms. A longer-term study reported that Invega Sustenna significantly increased the time before a relapse occurred.

In the past, paliperidone has only been available in a once-daily tablet. Now, the drug comes in pre-filled syringes to be used monthly after an initial two-week period. A 2006 study published in the Journal of Clinical Psychiatry found that schizophrenia patients on atypical antipsychotic drugs don’t take their medication for one-third of the year.

Paliperiodone palmitate is not approved for use in the very elderly, since studies showed an increased likelihood of death. Serious side effects of the drug include neuroleptic malignant syndrome (a dangerous illness caused by a bad reaction to antipsychotic drugs), changes in hearty rhythm, and tardive dyskinesia (a disorder similar to Tourette’s syndrome). Janssen Pharmaceuticals, a company owned by Johnson & Johnson, makes the drug.

AUTHOR: Annette Hulbert