FDA Approves Bristol-Myers' Abilify To Treat Irritabilty In Pediatric Patients With Autistic Disorder - Update

(RTTNews) - Biopharmaceutical company Bristol-Myers Squibb Co. (BMY: News ) and Otsuka Pharmaceutical Co., Ltd. said Friday that U.S. Food and Drug Administration or FDA has approved the supplemental New Drug Application or sNDA for Abilify for the treatment of irritability associated with autistic disorder in pediatric patients of ages 6 to 17 years.

The approval of Abilify for the treatment of irritation in patients with autistic disorder in pediatric patients is based on data from two eight-week, randomized, double-blind, placebo-controlled, multi-center, Phase III studies in which Abilify, compared to placebo, significantly improved scores on the Irritability subscale of the caregiver-rated Aberrant Behavior Checklist, the company said.

The commonly observed adverse reactions include sedation, fatigue, vomiting, somnolence, tremor, pyrexia, the company noted.

The efficacy of Abilify for the maintenance treatment of irritability associated with autistic disorder has not been evaluated, the company added.

While there is no approved treatment for the core symptoms of autistic disorder, irritability can be an associated behavior of autistic disorder and is manifested as aggression towards others, deliberate self-injurious behaviors, temper tantrums, aggression and quickly changing moods, the company noted. Behavioral problems such as irritability can be a source of impairment or distress to an individual with autistic disorder, the company added.

Birstol Meyers noted that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo mainly. The causes of death were varied, most of the deaths appeared to be cardiovascular or infectious, the company added.

The decision to initiate pharmacological treatment in children with irritability associated with autistic disorder should be made between healthcare providers and caregivers only after a thorough diagnostic evaluation and discussion of both the benefits and risks associated with pharmacological treatment, Bristol-Meyers said.

According to the American Psychiatric Association or APA's consensus guidelines on initiation of the treatment it is recommended for routine assessment and monitoring of patients' weight, waist circumference, blood pressure, fasting plasma-glucose level and fasting lipid profile for the development of metabolic adverse effects.

New York-based company' Bristol-Myers and Otsuka Pharma which had discovered are Abilify are collaborative partners in the development and commercialization of Abilify in the United States and major European countries, the company noted. Otsuka Pharma is a privately held company.

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