Janssen Pharmaceuticals announced the FDA approval of Invega (paliperidone) extended-release tablets for the acute treatment of schizoaffective disorder either as monotherapy or adjunctive therapy to mood stabilizers and/or antidepressants. The approval is based on two international, randomized, double-blind, placebo-controlled studies of patients with an established diagnosis of schizoaffective disorder, who were experiencing acute symptoms.
In the first six-week study, patients received flexible doses of Invega (3-12 mg once daily). In the other study, patients were assigned to one of two dose levels of Invega: 6mg with the option to reduce to 3mg, or 12mg with the option to reduce to 9mg. In addition to study medication, subjects were permitted to receive concomitant treatment with a mood stabilizer and/or antidepressant, provided these medications had been given at a stable dose within 30 days of screening. Approximately half the subjects enrolled received ongoing treatment with a mood stabilizer and/or antidepressant during the studies. The most commonly used mood stabilizers were valproate and lithium. The most commonly used antidepressants were SSRIs and SNRIs.
Efficacy was evaluated using the positive and negative symptom scale (PANSS). Mood symptoms were evaluated using the Hamilton Depression Rating Scale (HAM-D-21) and the Young Mania Rating Scale (YMRS). The INVEGA group in the flexible-dose study (dosed between 3 and 12 mg/day, mean modal dose of 8.6 mg/day) and the higher dose group of INVEGA in the 2 dose-level study (12 mg/day with option to reduce to 9 mg/day) were each superior to placebo in the PANSS. Numerical improvements in mood symptoms were also observed, as measured by the HAM-D-21 and YMRS. In the lower dose group of the 2 dose-level study (6 mg/day with option to reduce to 3 mg/day), INVEGA was not significantly different from placebo as measured by the PANSS.
Invega is a benzisoxazole already approved for the acute and maintenance treatment of schizophrenia.
For more information call (800) 526-7736 or visit www.invega.com