WASHINGTON -- The FDA has approved the injectable maintenance drug paliperidone palmitate (Invega Sustenna), making it the first once-monthly, atypical antipsychotic for schizophrenia.
The long-acting drug is approved for both acute and maintenance treatment.
The parent drug -- paliperidone in a once-daily tablet -- is an active metabolite of an old pharmaceutical, the atypical antipsychotic risperidone (Risperdal). (See Invega (paliperidone), Son of Risperdal (risperidone), Wins FDA Okay for Schizophrenia)
Researchers see once-monthly dosing as a potential solution for the medication adherence problems common in schizophrenia, noted Henry A. Nasrallah, MD, of the University of Cincinnati, an investigator in the paliperidone palmitate clinical trials.
"Inconsistent compliance with medications is arguably one of the single greatest impediments to managing the symptoms of schizophrenia and delaying the time to relapse," he said in a prepared statement.
Approval of the new, once-monthly formulation was based on four studies of acute symptom control and a longer-term, placebo-controlled maintenance study.
The maintenance study found significantly longer time-to-first relapse (the primary endpoint) among patients receiving paliperidone palmitate, compared with placebo (P<0.0001).
During the double-blind phase of the study, relapse rates were 10% and 34%, respectively. (See APA: Injectable Atypical Drug Slows Schizophrenia Recurrence)
Paliperidone palmitate comes in prefilled syringes. Recommended dosing starts with 234 mg and 156 mg injections into the deltoid muscle one week apart, followed by monthly 117 mg doses in the deltoid or gluteal muscle.
Paliperidone palmitate is not approved for treating dementia-related psychosis in the elderly, as clinical studies showed an increased likelihood of death.
Other potential negative side effects include weight gain, hyperglycemia, neuroleptic malignant syndrome, altered heart rhythm, and tardive dyskinesia.
The drug is manufactured by Janssen Pharmaceurticals of Titusville, N.J.