Pharmaceutical companies Otsuka and Lundbeck encounter obstacles in their acquisition bid for Rexulti, as the Food and Drug Administration raises doubts over the drug's effectiveness in treating post-traumatic stress disorder.
In a recent development, the US Food and Drug Administration (FDA) has flagged "discordant results" in the Phase III trials for Otsuka and Lundbeck's antipsychotic drug Rexulti, casting doubts on its potential expansion into post-traumatic stress disorder (PTSD) treatment.
Rexulti, an antipsychotic drug currently approved for use in schizophrenia and major depressive disorder, has been proposed for combination with the selective serotonin reuptake inhibitor sertraline (Zoloft) for the treatment of PTSD. The partners submitted findings from a randomized, double-blinded and placebo- and active-controlled Phase II study to bolster their application.
However, the discordant results have complicated the FDA's decision-making process. While some trials showed a statistically significant reduction in PTSD symptoms when Rexulti was combined with sertraline, another critical trial did not meet its primary endpoint, failing to demonstrate statistical significance compared to sertraline alone.
This inconsistency has raised concerns about the drug's efficacy for PTSD treatment. The FDA reviewers have highlighted that one of the Phase III trials clearly failed, which could undermine confidence in Rexulti's effectiveness. Moreover, the discordant results make it difficult for the FDA to interpret the data comprehensively, as there is no clear explanation for the inconsistencies.
The implications of these discordant results are significant. The FDA has delayed its decision on Rexulti's approval, and these results could lead to either a rejection of the application or further requirements for additional data. The agency has yet to provide a new target action date for Rexulti.
To address these concerns, the FDA has announced that it will hold an advisory committee meeting to discuss the application for Rexulti in PTSD, and as a result, it needs to extend its review period. The FDA's Psychopharmacologic Drugs Advisory Committee will convene on Friday to discuss the application.
In other news, Otsuka has acquired Cantargia's investigational anti-IL-1RAP, CAN10, for several autoimmune conditions. Additionally, upon closing, Otsuka will make a $33 million upfront payment with $580 million in potential milestone payments.
It is important to note that the Phase III trial with a flexible dosing regimen for Rexulti has not been discussed in the provided information, so no fact can be extracted from it at this time.
As the FDA review process continues, the future of Rexulti's expansion into PTSD treatment remains uncertain. The discordant results have introduced a degree of complexity into the approval process, making it challenging for the FDA to confidently assess Rexulti's suitability for treating PTSD.
- Science and healthcare industries are closely monitoring the FDA's review process for Otsuka and Lundbeck's antipsychotic drug Rexulti, as its potential expansion into post-traumatic stress disorder (PTSD) treatment is currently uncertain due to discordant results in Phase III trials.
- The health-and-wellness sector has expressed interest in Rexulti's proposed combination with the selective serotonin reuptake inhibitor sertraline (Zoloft) for PTSD treatment, but the inconsistency in trial results has sparked concerns about its efficacy.
- Mental-health advocates are closely following the FDA's decision-making process, as a rejection or further requirements for additional data could significantly impact the development of therapies-and-treatments for PTSD.
- The discordant results have also caught the attention of investors in the finance and business sectors, as they await a new target action date from the FDA for Rexulti.
- Technology and education-and-self-development platforms are reporting on the FDA's review of Rexulti, with general news outlets providing updates on the upcoming advisory committee meeting.
- Meanwhile, outside of Rexulti's PTSD development, Otsuka has made advancements in their autoimmune research with the acquisition of Cantargia's anti-IL-1RAP, CAN10, for several autoimmune conditions, showing their commitment to diversifying their therapies-and-treatments portfolio.
