JESS RODRIGUEZ/Adobestock
The US Food and Drug Advisory Committee voted not to recommend BREXPIPRAZOLE (Rexulti) with Set Lalin for post -traumatic stress disorder (PTSD). The panel believed that the efficacy was not well established to recommend approval. The vote was 10-1.
According to Arash Javanbakht, MD, the founding director of the stress, trauma, anxiety and research clinic of Wayne State University School of Medicine, about 13 million adult Americans experience PTSD in a given year, and about 6 out of 100 people have lifetime PTSDs for lifetime PTSD. I will hold it. The age group of 39-50 has the highest prevalence and women are more likely to have PTSD. In addition, 86%of the US population with PTSD is not a military, but civilians and civilians despite the beliefs of the public. When you have a PTSD diagnosis, 41%of the patients receive a multi -drug as the first treatment line. Then 70%of the treatment must be switched within the first two years of treatment. that. The most common reason for the change of treatment is “inappropriate/next book management of PTSD symptoms along with pre -treatment.”
In the past 25 years, two approved treatments for Humid and inconsistent PTSDs for managing PTSD symptoms for the past 25 years, the researchers have hoped to meet the unprecedented demands of Brexpiprazole.
BREXPIPRAZOLE is first used in PTSD space, while already on the market for other diseases. In 2015, it was approved by the FDA as an auxiliary therapy for adult antidepressants with major depressive disorders, and was most recently approved for the treatment of stirring related to alzheimer’s disease dementia in May 2023 as a single therapy for adults’ schizophrenia.
In clinical trials, Brexpiprazole + Sertraline received a two -phase three -step study (071 and 072). Research 071 was a flexible capacity (2-3 mg/day), 2-arm, randomization, control, dual blindness, multi-tube, 12 weeks. Research 072 was a fixed capacity (2 ~ 3 mg/day), 3-amar, random, control, double blindness, multi-center, 12 weeks. Research 071 was strongly positive, and Brexpiprazole + Sertraline was statistically significant that it was superior to Setal Rin alone. Research 072 was clearly negative, where Brekpypyzol + Set Lalin was not separated from Setralin alone. The investigator said, “Despite the extensive exploratory analysis, the reason for this inconsistency could not be identified.” There was also a first -stage study (061) similar to phase 3 studies. It was a flexible capacity (1 ~ 3 mg/day), 4-arm, randomization, control, double blind, multi-center, 12 weeks. Initially, it was designed as an exploratory study to generate hypotheses for the design of the 3rd stage program. After hypotheses, the use of the aftercut selection and the use of multi -test procedures cannot be insisted on statistical significance. However, it provides strong support evidence that was replicated in Research 071. Overall, the ratio of patients taking brexpiprazole + sertraline met a clinically significantly significant improvement threshold and achieved 30% clinical response.
Registration criteria were generally consistent in three studies. Participants were 18-65 years old and were diagnosed with PTSD DSM-5 MINI International Neuropsychiatric Interview was confirmed. It had to be symptoms for more than 6 months before screening and more than 33 CAPS-5 scores. The trauma type was not excluded.
Brexpiprazole + Sertraline is more effective than Setalin alone in two of these three studies. It was good, and the safety profile consistent with the large database of the clinical trial and the actual use of different psychiatric disorders.
The debate attempted to balance the disappointment of the three -stage results with the potential hope that this treatment can provide. Participants cited “confusing and contradictory data sets” and “discorded results”, but at the same time, the question is a study that is enough to study research 061. We are here because we are a difficult question here today. “
Kathleen Brady, MD, PHD, PHD, MD, PHD, MD, PHD, MD, PHD, MD, PHD, PHD, MD, PHD, PHD, MD, PHD, MD, PHD, PHD said, “ “I will be disappointed,” he said, “I would be disappointed,” he said. “I would be disappointed if I interfered with the ability to discuss and evaluate the clinical disorders that could discuss and evaluate the entire data presented today.”
This is the second PTSD treatment for negative advisory committee votes. In August 2024, the FDA announced a complete response letter to the MDMA-AT for PTSD and requested an additional three-stage exam to investigate safety and efficacy rather than hallucinations.
A panelist who opposes the recommending brexpiprazole + sertraline said, “People have experienced a lot and this vote can be disappointing, which requires additional data to persuade the current FDA’s treatment for this disease.
A Psychiatric time Drug Watch Special Report, editor-in-chief of MD John J. Miller, is an immediate response to Michael Asbach, DMSC, PA-C, Psych-Caq and Erin Crown, MHS, PA-C, PSYCH-CAQ and July 18 I talked about the effect of practice.
