Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), today announced that the U.S. Food and Drug Administration (FDA) recently accepted for review the lurasidone New Drug Application (NDA) for the treatment of patients with acute schizophrenia. The NDA was submitted to FDA on December 30, 2009 and will receive a standard review.
"We are pleased that the lurasidone NDA has been accepted for review by the FDA," said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd. "We look forward to the potential lurasidone may bring as it represents our commitment to developing therapies that provide clear value to patients and health care professionals."
The lurasidone NDA includes data from more than 40 clinical studies involving more than 2,500 lurasidone-treated patients. The efficacy and safety of lurasidone were evaluated in five six-week, placebo-controlled studies, involving hospitalized patients with schizophrenia. In four of these studies, lurasidone demonstrated significantly greater improvement versus placebo on the primary efficacy measure, the Positive and Negative Syndrome Scale (PANSS) total score, at study endpoint. In all five studies, lurasidone was well-tolerated and associated with limited weight gain or changes in metabolic parameters. In addition, patients treated with lurasidone exhibited mild changes in movement disorder parameters and prolactin levels.
Lurasidone is an atypical antipsychotic agent with a unique chemical structure. Lurasidone has high affinity for dopamine D(2), serotonin 5-HT(2A) and serotonin 5HT(7) receptors where it has antagonist effects. In addition lurasidone is a partial agonist at the serotonin 5HT(1A) receptor. It has no appreciable affinity for histamine or muscarinic receptors.