Drug Reduces Schizoaffective Relapse in Preliminary Trial

Results from a schizoaffective disorder prevention study have shown Invega Sustenna (paliperidone palmitate) successfully reduces the risk of schizophrenia relapse and improves and maintains patient functioning in manic and depressive mood symptoms and psychosis, Johnson & Johnson announced May 5, 2014, at the annual meeting of the American Psychiatric Association, held in New York City.

In light of those positive preliminary results, the company plans to submit a supplemental New Drug Application with the US Food and Drug Administration (FDA) in the near future.

“Even though it is associated with a high risk of hospitalization, suicidality, and substance abuse, schizoaffective disorder isn't the subject of extensive research, leaving clinicians with a complex polypharmacy approach to treatment,” David P. Walling, PhD, Chief Executive and Clinical Officer of the Collaborative NeuroScience Network, Inc., in Los Angeles, said in a press release. “Subject to FDA approval, Invega Sustenna has the potential to be an additional option as the only long-acting injection indicated to treat schizoaffective disorder.”

The trial examined 334 adult schizoaffective patients who experienced psychotic and mood symptoms. After receiving Invega Sustenna as monotherapy or in conjunction with antidepressants or other mood stabilizers for 13 weeks, the patients continued into a 12-week stable dose period, which lasted until discontinuation or completion after 15 months.

In the placebo group, 57 (33.5%) patients relapsed, which was defined as a psychiatric hospitalization or any intervention to prevent hospitalization due to worsening symptoms, while 25 (15.2%) patients relapsed in the Invega Sustenna group. Regardless of whether Invega Sustenna was taken alone or with antidepressants or mood stabilizers, the researchers found in a further analysis that the drug was more likely to be successful over a placebo.

Side effects from Invega Sustenna treatment included weight gain, insomnia, worsening of schizoaffective disorder, headache, nasopharyngitis, and movement disorders such as akathisia and tremor.