Health Canada accepts Sunovion Pharmaceuticals Canada's lurasidone NDS for review

Aug 24 2011

- NDS Included 48 Clinical Studies including more than 2,900 Patients Treated with Lurasidone -

Sunovion Pharmaceuticals Canada Inc., formerly Sepracor Pharmaceuticals, Inc., today announced that the New Drug Submission (NDS) for Lurasidone HCl, for the treatment of adult patients with schizophrenia has been accepted for review by Health Canada. The NDS was submitted to Health Canada in June 2011 and will receive a standard review.

"We are pleased that the lurasidone NDS has been accepted for review by Health Canada," said Douglas Reynolds, President, Sunovion Pharmaceuticals Canada Inc. "This acceptance marks a significant milestone for our company as we look to bring an innovative new treatment option for schizophrenia to patients, caregivers and healthcare professionals in Canada."

The lurasidone NDS includes data from 48 clinical studies involving more than 2,900 lurasidone-treated patients. The efficacy of lurasidone was demonstrated in five six-week, placebo-controlled studies, involving hospitalized patients with schizophrenia. These studies included the three global PEARL (Program to Evaluate the Antipsychotic Response to Lurasidone) clinical trials. In clinical trials, lurasidone was tolerable and associated with low rates of change in metabolic parameters, including weight versus placebo. The most common adverse events associated with lurasidone are somnolence, akathisia, nausea, and parkinsonism.

Lurasidone is an atypical antipsychotic agent with a chemical structure that has high affinity for dopamine D_2, serotonin 5-HT_2A and serotonin 5-HT₇ receptors where it has antagonist effects. In addition, lurasidone is a partial agonist with moderate affinity at the serotonin 5-HT_1A receptor. Lurasidone exhibits little or no affinity for histamine H₁ and muscarinic M₁ receptors.

Lurasidone is currently available in the United States and Puerto Rico under the brand name LATUDA^® in 40 mg and 80 mg once-daily tablets.