![]() ![]() ![]() The primary endpoint was to demonstrate similar efficacy between aripiprazole 2-month ready-to-use LAI and aripiprazole once-monthly 400 mg over a 2-month dosing interval. #Ambify drug trial#In clinical trial 031, researchers evaluated the efficacy and safety of aripiprazole 2-month ready-to-use LAI for schizophrenia and bipolar I disorder. “The trial results reinforce the long-standing efficacy and safety profile of the once-monthly aripiprazole long-acting injectable.” “This is an important milestone in our efforts to offer adult patients with schizophrenia or bipolar I disorder a new option designed to support treatment goals and offer greater flexibility,” said Johan Luthman, executive vice president, Lundbeck Research & Development, in a press release. ![]() The delivered and sustained plasma concentrations will be similar to those in the once-monthly LAI. If approved, aripiprazole 2-month, ready-to-use LAI would be available in either a 960 mg or 720 mg prefilled syringe administered as an intramuscular injection into the gluteal muscle every 2 months. The decision was announced by Otsuka America Pharmaceutical, Inc, and H. The FDA also accepted the drug’s NDA to be used as a maintenance monotherapy for bipolar I disorder. Other studies showed that Abilify was more effective than placebo at preventing manic episodes in previously treated adults for up to 74 weeks, and when it was used as an add-on to existing treatment.Ī study in 296 children and adolescents showed that Abilify was more effective than placebo at reducing the manic symptoms in patients aged 13 years and older.įinally, a study in 291 patients treated by injection for agitation and disturbed behaviour showed that improvement with Abilify was greater after 2 hours than with placebo and similar to that with lorazepam (another medicine for treating agitation).The FDA has accepted a New Drug Application (NDA) for aripiprazole 2-month, ready-to-use, long-acting injectable (LAI) to treat adults with schizophrenia. In 4 out of 5 studies in 1,900 adults, Abilify was more effective than placebo at reducing manic symptoms, with two of these studies showing that Abilify has a similar effect to haloperidol and to lithium. Studies in bipolar I disorder showed that Abilify is effective at treating manic episodes using standard measurements such as the Young-Mania Rating Scale (YMRS) scale. ![]() In another adult study, Abilify was as effective as haloperidol, another antipsychotic medicine, in preventing symptoms from returning over 1 year.Ībilify has also been studied in 302 adolescents aged between 13 and 17, with results showing Abilify to be more effective than placebo.Ī study in 544 patients treated by injection for agitation and disturbed behaviour showed that improvement with Abilify over 24 hours was greater than with placebo and similar to that with haloperidol. In studies of 1,203 adults, Abilify was more effective than placebo (a dummy treatment) at reducing symptoms. Studies showed that Abilify is effective at treating symptoms of schizophrenia using standard rating scales (such as the Positive and Negative Syndrome Scale, PANSS). ![]()
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