Medical Network March 21, March 19, the FDA approved Sage Therapeutics' new drug Zulress (brexanolone) for the treatment of postpartum depression. This drug significantly improved the patient's depression scale score after 60 hours of injection.
On November 2nd last year, the FDA Psychiatric Pharmacology Advisory Committee and the Drug Safety and Risk Management Advisory Committee supported the brexanolone approval for a 17:1 vote, but asked Sage to submit a proposed risk assessment and mitigation strategy to the FDA. (REMS), which contains elements to ensure safe use (ETASU). The FDA also announced on November 23 that Zulress' approval period will be extended by three months, from December 19, 2018 to March 19, 2019.
Developed by Sage, Brexanolone is an allosteric modulator of synaptic and extrasynaptic gamma-aminobutyric acid type A receptors (GABAA receptors). GABAA receptors and NMDA (N-methyl-D-aspartate) receptors act to inhibit and stimulate brain neurons to produce nerve impulses, respectively. The imbalance between the two receptor activities is responsible for a variety of mental illnesses including depression.
Before Brexanolone's phase III clinical failure for super-refractory epilepsy, stocks fell 14%. Fortunately, Sage's R&D team is unyielding and extends clinical trials to postpartum depression.
The results of a phase III clinical study recently published in The Lancet showed that all doses of the brexanolone treatment group achieved the expected efficacy. At the 60th hour of treatment, the brexanolone treatment group had a depression scale score compared with the placebo group. Significantly lower.
The Phase III study was conducted in 30 US medical centers, aged 18-45 years, less than 6 months postpartum, 17 Hamilton Depression Rating Scale (HAMD) scores ≥ 26 (Study 1), or HAMD scores 20-25 (Study 2) Maternal women were randomized to receive 90 μg/kg/h brexanolone (BRX90), 60 μg/kg/h brexanolone (BRX60) or placebo for 60 hours. The primary efficacy endpoint was a 60-hour HAMD score change.
138 maternal women participated in the study1, divided into BRX90 group (n=45), BRX60 group (n=47) primary placebo group (n=46), 108 patients participated in study 2, divided into BRX90 group (n=54) ) and placebo group (n=54). In Study 1, after 60 hours, the HAMD score in the BRX60 group decreased by 19.5 compared with baseline, the BRX90 group decreased by 17.7, and the placebo group decreased by 14.0. In Study 2, the 60-hour HAMD score in the BRX90 group decreased by 14.6 compared with baseline, and the placebo group decreased by 12.1. The most common treatment-related adverse events for brexanolone were headache, dizziness, and lethargy. Four treatment-related serious adverse events occurred, including suicidal ideation, intentional drug overdose, altered state of consciousness, and syncope during follow-up.
PPD is an obvious and easily recognizable major depression that usually begins in the third trimester of pregnancy or within 4 weeks of delivery. It is the leading cause of maternal postpartum suicide and the most common medical complication of childbirth. The main clinical manifestations include obvious dysfunction, depression, loss of interest in newborns, and associated symptoms of depression such as loss of appetite, sleep disturbance, inattention, listlessness, lack of self-esteem, and suicidal tendencies. More than half of the first episodes of PPD will recur in the next 5 years, and one third of patients will relapse within the first year.
There are 300 million postpartum depression patients in the world, about 400,000 cases per year in the United States. The prevalence of PPD reported in China is 1.1% to 52.1%, with an average of 14.7%, and 50% to 80% of them have postpartum depression. However, there is currently no FDA-approved postpartum depression therapy, and there are significant medical needs in this area that are not being met.
4G Solar Camera Network ,Solar Camera Wifi,Solar Camera Outdoor,Outdoor Security 4G Solar Camera