Topic: Otsuka Pharmaceutical Co. Ltd.

The cost regulator for the U.K.'s publicly-funded National Health Service Wednesday recommended Bristol-Myers Squibb ...

Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced today that an independent data monitoring committee (IDMC) has recommended the early termination of its Phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial. Oral formulations of aripiprazole (including tablets, orally disintegrating tablets and oral solution) are co-marketed by Otsuka and Bristol-Myers Squibb under the brand name, ABILIFY . In addition, ABILIFY (aripiprazole) Injection is also co-marketed by Otsuka and Bristol-Myers Squibb for treatment of agitation in schizophrenia in adults. ABILIFY is not approved for the treatment of patients with dementia-related psychosis. Cerebrovascular Adverse Events, Including Stroke- Increased incidence of cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with ABILIFY Neuroleptic Malignant Syndrome (NMS) - As with all antipsychotic medications, a rare and potentially fatal condition known as NMS has been reported with ABILIFY. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn Hyperglycemia and Diabetes Mellitus - Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics including ABILIFY. Strong CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, fluoxetine) inhibitors will increase ABILIFY drug concentrations; reduce ABILIFY dose by one-half when used ...

BMY) and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized ...