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Home Industry News Consumer Brexpirazole PTSD Treatments sNDA Accepted by FDA

Brexpirazole PTSD Treatments sNDA Accepted by FDA

26th June 2024

The FDA has approved brexpiprazole’s supplementary new drug application for the therapy of PTSD.

The FDA approved the supplementary new drug application for the management of adults with PTSD using brexpiprazole and sertraline. This might advance the approval process and provide patients with more sophisticated therapy alternatives. The choice was made using information from three randomised clinical studies that showed how safer and more tolerable the treatment was for PTSD sufferers.

The sNDA for brexpiprazole has been accepted in the management of adults with PTSD, which represents a rising development in patient therapy choices. The study results demonstrate the effectiveness of brexpiprazole, which suggests that it may be a promising supplementary therapy choice for treating the complex demands of PTSD patients.

Johan Luthman, PhD, executive vice president of Lundbeck Research & Development, Stated: “Brexpiprazole in combination with sertraline could represent an important advancement over current standard of care, and we look forward to working with the FDA in the process of seeking approval of this combination.”

He continued: “We are grateful to the patients and caregivers who participated in these important trials.”

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