Bukwang Pharm proves non-inferiority of schizophrenia treatment 'Lurasidone'

[Asia Economy Reporter Chunhee Lee] Bukwang Pharmaceutical has succeeded in demonstrating the non-inferiority of 'Lurasidone,' introduced as a treatment for schizophrenia and bipolar depression, compared to existing treatments.

On the 22nd, Bukwang Pharmaceutical disclosed the topline results of the Phase 3 clinical trial of Lurasidone containing this information. Lurasidone is an atypical antipsychotic for schizophrenia and bipolar depression developed by Sumitomo Pharma in Japan, and in 2017, Bukwang Pharmaceutical secured exclusive development and distribution rights in Korea. It is an antagonist that blocks dopamine D2, serotonin 5-HT 2A, and serotonin 5-HT 7 receptors.

This clinical trial was conducted at 35 hospitals, including Boramae Hospital, targeting 210 patients with acute psychotic symptoms of schizophrenia. The primary endpoint was set as the mean change in the Positive and Negative Syndrome Scale (PANSS) total score at 6 weeks compared to baseline.

As a result, the PANSS score in the Lurasidone treatment group (PP group) was -6.35, which was greater than the non-inferiority margin set at -8.99, satisfying efficacy. Statistical significance for non-inferiority was confirmed compared to the atypical schizophrenia treatment 'Quetiapine' currently marketed domestically.

A Bukwang Pharmaceutical official stated, "Based on these clinical results, we plan to submit the new drug approval documents to the Ministry of Food and Drug Safety in the fourth quarter," adding, "Lurasidone is a major product with potential annual sales of several hundred billion KRW, and we will further focus on strengthening the central nervous system (CNS) product portfolio and boosting sales growth.”

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