The FDA has delivered a complete response letter to Lundbeck and Otsuka, effectively halting their plans to market the atypical antipsychotic Rexulti in conjunction with Viatris’ Zoloft as a new treatment option for post-traumatic stress disorder (PTSD). This decision follows a recent advisory committee meeting where the drug faced significant scrutiny and received a negative vote, raising concerns about its efficacy and safety profile in this specific patient population.
This rejection underscores the challenges pharmaceutical companies face in gaining regulatory approval for new indications, particularly in complex and sensitive areas like mental health. The FDA’s decision reflects a cautious approach to novel therapies for PTSD, emphasizing the need for robust clinical evidence to support claims of benefit. As Lundbeck and Otsuka reassess their strategy, this outcome may prompt other companies to reconsider their development pipelines in the PTSD space, potentially delaying innovation in treatments for this condition.
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