Bukwang Pharmaceutical said its local phase 3 clinical trial of lurasidone successfully treated schizophrenia and bipolar disorder, drawing attention from the pharmaceutical industry.

In a public filing on Thursday, Bukwang disclosed the topline results of the local phase 3 study.

The company said the study was successful because it reached the primary endpoint with statistical significance.

Earlier, Bukwang conducted the randomized, double-blind phase 3 trial in 210 acutely psychotic patients with schizophrenia at 35 Korean hospitals, including SMG-SNU Boramae Medical Center.

According to the filing, the study's primary endpoint was set as changes in the Positive and Negative Syndrome Scale (PANSS) to assess lurasidone’s non-inferiority to an existing drug.

Bukwang said it confirmed lurasidone’s non-inferiority to quetiapine, a drug for atypical schizophrenia marketed in Korea.

However, the company did not disclose the safety profiles but said it would do so later.

Based on the latest study outcomes, the company will write a clinical study report, submit it to the Ministry of Food and Drug Safety, and apply for approval in the fourth quarter.

Lurasidone is an antipsychotic developed by Sumitomo Pharma to treat atypical schizophrenia and bipolar disorder. The treatment is being sold under the trade name, Latuda after the FDA nod in 2010.

Lurasidone is known to lower the risk of weight gain, one of the adverse effects of conventional antipsychotics.

In 2017, Bukwang signed a deal with Sumitomo Pharma to secure the rights to develop and commercialize lurasidone.

According to Bukwang, lurasidone was authorized in the U.S. to treat adults and adolescents aged 13 to 17 with schizophrenia and adults and pediatric patients aged 10 to 17 with Bipolar I Disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

Bukwang said lurasidone obtained approval to treat schizophrenia in more than 45 countries, including the EU, the U.K., Switzerland, Russia, Japan, China, Singapore, Thailand, Hong Kong, Taiwan, Australia, United Arab Emirates (UAE), Kuwait, Saudi Arabia, and Brazil.

The company emphasized that lurasidone was a blockbuster drug that sold $1.74 billion in North America in 2019.

“Lurasidone may sell scores of billions of won annually. Therefore, the company will make more efforts to enhance the portfolio of central nervous system (CNS) products and increase sales,” an official at Bukwang said.