Once-daily schizophrenia drug lurasidone under FDA review in US: Dainippon Sumitomo Pharma

Lurasidone, a once-daily treatment for schizophrenia, may soon hit the US markets, according to Dainippon Sumitomo Pharma America.

A New Drug Application (NDA) seeking permission to market lurasidone has been submitted to the U.S. Food and Drug Administration  for lurasidone, Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP) announced in a press statement.

Lurasidone is an investigational atypical antipsychotic agent for the treatment of schizophrenia.

Lurasidone has been studied in more than 40 clinical studies involving more than 2,500  patients.

“We believe lurasidone will be a valuable new option for patients, their families and physicians for the treatment of schizophrenia,” stated Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd.

The efficacy of once-daily lurasidone was demonstrated in four six-week, placebo-controlled studies, involving hospitalized patients with schizophrenia. These studies included the global PEARL 1 and PEARL 2 clinical trials (Program to Evaluate the Antipsychotic Response to Lurasidone).

Lurasidone was generally well-tolerated with limited weight gain or changes in metabolic parameters. Furthermore, lurasidone was associated with mild changes in movement disorder parameters and prolactin levels, clinical trials found.

Lurasidone was discovered and developed by Dainippon Sumitomo Pharma Co., Ltd. Lurasidone has high affinities for dopamine D(2), serotonin 5-HT(7), 5-HT(2A), 5-HT(1A), and noradrenaline alpha(2C) receptors and minimal-to-no affinity for histamine H(1) or cholinergic M(1) receptors.

Schizophrenia is a chronic, disabling and serious medical illness that affects between two to three million American adults and more than 24 million adults worldwide.

Schizophrenia affects men and women equally and occurs at similar rates in all ethnic groups around the world. Schizophrenia is a treatable medical condition and is thought to be caused by a combination of environmental and genetic factors.

The condition is characterized by positive and negative symptoms, such as hallucinations, delusions, disorganized thinking, lack of emotion, lack of energy, as well as cognitive impairments including problems with memory, attention and the ability to plan, organize and make decisions.

In 2002, the overall cost of schizophrenia in the United States was estimated to be $62.7 billion, with $22.7 billion in direct health care costs.

Dainippon Sumitomo Pharma America, Inc. located in Fort Lee, N.J., is a subsidiary of Dainippon Sumitomo Pharma Co., Ltd.

DSP is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical, animal health and food and specialty products and strong research and development presence in the areas of CNS, diabetes, cardiovascular disease, and inflammation/allergy. In October 2009, Sepracor Inc., based in Marlborough, MA, became a subsidiary of DSP.