The long-acting, injectable antipsychotic Invega Sustenna (paliperidone palmitate), which is given monthly, was found to be effective for six months longer than oral antipsychotics commonly prescribed for schizophrenia, according to a study conducted by the drug’s manufacturer, Janssen.
The PRIDE (Paliperidone Palmitate Research In Demonstrating Effectiveness) study enrolled 444 people in a 15-month, prospective, randomized, open-label, active-controlled study. Patients were randomly given either Invega Sustenna (78–234mg) or one of seven flexibly-dosed, common daily oral antipsychotics: aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone.
The primary endpoint was time to first treatment failure or relapse. Invega Sustenna delayed relapse for a median of 416 days, compared to a median of 226 days with oral antipsychotics, according to study results published The Journal of Clinical Psychiatry.
The FDA is reviewing a supplemental New Drug Application to update labeling for Invega Sustenna to include the new data from the trial. The action date is May 11.
In an opinion piece for Psychiatry Advisor last year, John Kane, MD, chairman of the Department of Psychiatry at the Hofstra North Shore-LIJ School of Medicine, wrote that long-acting antipsychotics provide distinct advantages for patients, including improved patient adherence and a reduction in relapse.
Alphs L, et al. Real-World Outcomes of Paliperidone Palmitate Compared to Daily Oral Antipsychotic Therapy in Schizophrenia: A Randomized, Open-Label, Review Board–Blinded 15-Month Study. J Clin Psychiatry. 2015; doi:10.4088/JCP.14m09584.