FDA approves twice-yearly schizophrenia treatment

The Janssen Pharmaceutical Companies of Johnson & Johnson announced FDA approval of Invega Hafyera, a twice-yearly injectable antipsychotic for adults with schizophrenia.

The approval of this 6-month paliperidone palmitate is based on a randomized, double-masked, noninferiority phase 3 global study that assessed 702 patients with schizophrenia, the company said in a press release.

The study found that 95% of patients treated with Invega Trinza (3-month paliperidone palmitate, Janssen) and 92.5% of patients treated with Invega Hafyera were relapse-free after 12 months. Relapse was defined in the release as psychiatric hospitalization, increase in Positive and Negative Syndrome Scale (PANSS) total score, increase in individual PANSS item scores, self-injury, violent behavior or suicidal/homicidal ideation.

“For too long, we’ve accepted relapse as a normal part of living with schizophrenia, while research continues to demonstrate that stronger medication adherence means better patient outcomes,” Gustavo Alva, MD, DFAPA, medical director at ATP Clinical Research and clinical trial investigator, said in the release. “The phase 3 trial results provide compelling evidence that 6-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence.”

Study results showed common adverse reactions (with an incidence of at least 5%) to the treatment included respiratory tract infections, injection site reactions, weight increase, headaches and parkinsonism (12%, 11%, 9%, 7% and 5%, respectively). According to the release, 6-month paliperidone palmitate can result in cerebrovascular problems for older patients with dementia-related psychosis, as well as neuroleptic malignant syndrome.

Patients with schizophrenia must be treated with either 3-month paliperidone palmitate or Invega Sustenna (1-month paliperidone palmitate, Janssen) before transitioning to 6-month paliperidone palmitate, the company said in the release.

“Long-acting injectable treatments offer a number of advantages compared to oral medication for schizophrenia, including relief from needing to remember to take medication daily, lower discontinuation rates and sustained treatment over longer periods,” Bill Martin, PhD, global therapeutic area head, neuroscience, Janssen Research & Development, said in the release. “Today’s approval enables us to rethink how we manage this chronic disease by offering patients and caregivers the potential for a life less defined by schizophrenia medication.”