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Phase III results with Invega Sustenna/Xeplion (paliperidone palmitate) in Schizophrenia published in JAMA- Janssen

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Last updated:30th Mar 2015
Published:30th Mar 2015
Source: Pharmawand

Three-month treatment with Invega Sustenna/Xeplion (paliperidone palmitate), from Janssen Pharmaceuticals, significantly delayed time to relapse compared to placebo in patients with schizophrenia, according to a new Phase III clinical study published in the Journal of the American Medical Association (JAMA) Psychiatry. The final published analysis results are consistent with previously announced interim analysis results which showed a statistically significant benefit of three-month paliperidone palmitate compared to placebo.

The most common treatment-emergent adverse events (TEAEs), which occurred in at least 3% of patients in the double-blind phase of the study and that occurred more frequently in the three-month paliperidone palmitate group than placebo group, were headache (9% vs. 4%), increased weight (9% vs. 3%), nasopharyngitis (6% vs. 1%) and akathisia, a movement disorder (4% vs. 1%).

Results of the study served as the basis for the recent New Drug Application (NDA) filing for three-month paliperidone palmitate injection to treat schizophrenia in adults with the FDA by Janssen Research & Development. The FDA granted the filing Priority Review status in January, with a regulatory action date of May 18, 2015.

See: Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial.

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