Danish pharmaceutical company Lundbeck has suffered a setback in the United States after an FDA advisory committee voted 10-1 against the demonstrated efficacy of Rexulti, in combination with sertraline, for the treatment of post-traumatic stress disorder (PTSD) in adults. This decision marks a significant obstacle for both Otsuka and Lundbeck, though the companies have expressed their intention to continue working with the FDA throughout the ongoing review process.
The application was based on three clinical studies involving nearly 1,300 patients in total.
"Although today's outcome was disappointing, we remain committed to collaborating with the FDA as they complete their review of this application," said John Kraus, M.D., Ph.D., Executive Vice President and Chief Medical Officer at Otsuka.
"We continue to believe in the potential of brexpiprazole to make a meaningful difference as a treatment option for patients with PTSD," he added.
