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news.Otsuka Pharmaceutical and Bristol-Myers Squibb have announced that the FDA has approved the drug Abilify for the treatment of schizophrenia in adolescents aged 13-17 years.
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This approval is based on results from a six-week, randomized, double- blind, placebo-controlled study that demonstrated significant improvement with Abilify compared to placebo on the primary efficacy endpoint, positive and negative syndrome scale (PANSS) total score.
Tatsuo Higuchi, president and representative director at Otsuka Pharmaceutical, said: “We are extremely pleased that Abilify, the first available dopamine partial agonist, is approved for the treatment of pediatric patients (13 to 17 years of age) suffering from schizophrenia. Abilify offers an effective new option to help treat this serious mental illness.”
Elliott Sigal, executive vice president, chief scientific officer and president of R&D at Bristol-Myers Squibb, said: “Schizophrenia is one of the most complex of all mental health disorders. We remain committed to providing innovative therapies, such as Abilify, to help patients, including adolescents, living with schizophrenia.”