New antipsychotic drugs! Lingbei and Otsuka Brexpiprazole Treat Post-Traumatic Stress Disorder (PTSD) Phase II Clinical Master:

Otsuka, a Japanese pharmaceutical company, and lundbeck, a partner, recently jointly announced positive results in the evaluation of The Phase II Clinical Study (NCT03033069) of Rxulti (Brexpiprazole) for the treatment of post-traumatic stress disorder (PTSD). The two sides have planned to meet with the FDA to discuss the results of this Phase II study and to evaluate the next steps in the Brexpiprazole clinical program.
The study, a randomized, double-blind, placebo and active drug control Phase II study, was launched in 2017 and included 321 adult PTSD patients to assess the efficacy, safety and tolerability of flexible dose brexpiprazole as a single-drug therapy and in combination therapy with flexible dose sertraline. The study included a 12-week double-blind treatment period (including 1 week placebo introduction) and a 14-day follow-up period (14 days after the last dose). In the study, patients were randomly assigned to four treatment groups: (1) brexpiprazole single-drug treatment group (flexible dose) ;(2) Shequlin single-drug treatment group (flexible dose) ;(3) brexpiprazole and sherralin combined treatment group (flexible dose) ;(4) placebo group. The main end point of efficacy is the average change in the total score of the clinician-specific PTSD scale DSM-5 revision (CAPS-5) from the baseline to the 12th week of treatment.
results showed that the PTSD symptoms in the brexpiprazole-Shequlin combined treatment group (rated with CAPS-5 total score) showed significant improvement (p<0.01) compared to the placebo group, reaching the main therapeutic endpoint of the study and also reaching several secondary endpoints. However, compared to the placebo group, the symptoms of PTSD in the brexpiprazole single-drug treatment group and the single-drug treatment group in Shequlin showed no clinically significant improvement (p>0.35, p>0.60, respectively).
study, the overall safety and toaling of brexpiprazole monotherapy, brexpiprazole and Shequlin combination therapy were good (as compared to previous data). The placebo group reported one death.
Brexpiprazole is a second-generation (atypical) oral antipsychotic drug that was discovered by Otsuka and developed jointly by Lingbei and Otsuka. In the U.S. market, brexpiprazole was approved by the FDA in July 2015 for complementary treatment for adult patients with severe depression (MDD) and for adult patients with schizophrenia. At the end of September 2016, the FDA approved the expansion of the brexpiprazole drug label to include data on the efficacy and safety of long-term maintenance treatment in adult patients with schizophrenia. In Europe, brexpiprazole was approved in 2018 for the treatment of adult patients with schizophrenia. Brexpiprazole's brand name is Rexulti in the U.S. market and Rxulti in the European market.
Post-traumatic Stress Disorder (PTSD) is a mental disorder that occurs, is caused by an individual experiencing, witnessing, or experiencing the actual death of one or more individuals involving himself or herself or others, or being threatened with death, or serious injury, or threat to the integrity of the body. The incidence of PTSD varies (0.2-4%) between different populations and countries.
at present, the exact mechanism of action of brexpiprazole is not known, the efficacy of the drug may be through 5-HT1A receptor and dopamine D2 receptor part of the astrogen activity, serotonin 5-HT2A receptor antagonist activity co-mediated. In addition, brexpiprazole showed high affinity for these subjects (subnamore, subnanomolar) and high affinity for normodyne alpha 1B/2C. (Bio Valley)