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Vanda Pharmaceuticals Unveils BYSANTI™ Approval

Vanda Pharmaceuticals Inc. has announced a significant milestone in psychiatric treatment with the recent FDA approval of BYSANTI™ (milsaperidone). This new medication is designed for the acute treatment of manic or mixed episodes associated with Bipolar I Disorder and schizophrenia in adults.

Overview of BYSANTI™

BYSANTI™ is classified as an atypical antipsychotic and represents a new chemical entity (NCE). Clinical studies reveal that BYSANTI™ shows bioequivalence to iloperidone, paving the way for a newly established treatment option that builds upon an extensive clinical heritage. The data stem from a robust clinical development program and encompass over 100,000 patient-years of real-world experience with Fanapt® (iloperidone). As a result, BYSANTI™ offers a trustworthy option while addressing serious psychiatric conditions.

Dr. Mihael H. Polymeropoulos, President and CEO of Vanda Pharmaceuticals, expressed that "BYSANTI™ marks a substantial advancement, providing a dependable new treatment grounded in comprehensive clinical heritage." He stressed that the approval reflects an accelerated innovation era in drug development aimed at addressing significant needs in behavioral health.

Mechanism and Efficacy

BYSANTI™ operates through a unique mechanism, functioning as it interconverts into iloperidone. This dual-action nature allows both active molecules to work together, antagonizing dopamine D2, serotonin 5-HT2A, and alpha1-adrenergic receptors to modulate critical pathways connected to these disorders. Its safety profile closely aligns with that of iloperidone, enhancing its appeal for widespread clinical application.

Moreover, BYSANTI™ is currently under investigation in an ongoing clinical study as a once-daily treatment adjunct in patients with treatment-resistant major depressive disorder. This study is anticipated to conclude by the end of this year, potentially leading to broader applications for the medication.

Future Considerations

A distinguishing feature of BYSANTI™ is its in-class receptor-binding profile, which reveals a pronounced alpha-adrenergic binding surpassing that of dopamine and serotonin receptors. This characteristic opens the potential for research into treating additional symptoms linked to various psychiatric disorders, including agitation, hostility, and hyperarousal.

Vanda Pharmaceuticals is preparing for the commercial launch of BYSANTI™ in the third quarter of 2026. The drug's marketing exclusivity will be safeguarded by regulatory data exclusivity and U.S. patents expiring in 2044, promising sustained innovation to support patients in need.

The approval of BYSANTI™ comes just two months after the company received approval for another product, NEREUS™, demonstrating Vanda's momentum in delivering innovative solutions to critical health concerns.

Understanding Bipolar I Disorder and Schizophrenia

Bipolar I disorder affects a notable portion of the estimated 10 million individuals in the U.S. with bipolar disorder, necessitating effective management of manic or mixed episodes to enhance patient outcomes. Likewise, schizophrenia, impacting around 1% of adults in the country (approximately 2.8 million people), often leads to profound functional impairments and frequent hospitalizations, marking it as a serious concern in mental health.

As BYSANTI™ joins the arsenal of available treatments for these conditions, it symbolizes hope for improved management strategies and a better quality of life for those affected. For full prescribing information, including warnings and safety information, it is recommended to visit www.bysanti.com.