Dainippon Sumitomo Pharma America Gets FDA Nod For Lurasidone

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 the studies, lurasidone has demonstrated 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 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.

Masayo Tada, president and chief executive officer of Dainippon Sumitomo Pharma, said: “We are pleased that the lurasidone NDA has been accepted for review by the FDA. 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.”