Mengke Pharmaceutical's Class 1 new drug `` Contezolamide '' declared for listing
Release date: 2020-01-06 Views: 0
On January 4, CDE's official website showed that Mengke Pharmaceutical's first antibacterial new drug Kangtaizolamide tablet was approved by CDE.
Contezodazole is an oral oxazolidinone antibacterial drug designed to treat infections caused by resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). Physicians and patients offer a treatment option that is safer and better tolerated than existing oxazolidinones.
The results of a pivotal phase III clinical study for the treatment of complex skin and soft tissue infections (cSSTIs) indicate that the rate of clinical cure of contazodamine during the primary endpoint cure test period (TOC, 7-14 days after the last dose), Non-inferior to linezolid and show lower drug-related hematological adverse events.
This double-blind trial was carried out in 50 clinical centers in China. Patients with complex skin and soft tissue infections were randomly assigned to receive 800 mg of oral conazolamide or 600 mg of linezolid twice a day for 7 to 14 days. Of the 719 patients enrolled, 589 patients were clinically evaluable (CE) at the time of the TOC visit.
In the CE population, the clinical cure rate of contezolid during TOC visits was comparable to that of linezolid, 93.0% and 93.4%, respectively, reaching the non-inferiority target of -10%. In addition, all secondary efficacy indicators, including the clinical cure rate at the end of treatment visit (EOT), the microbial clearance rate at the TOC visit, and the comprehensive response rate at the TOC visit, the 95% confidence interval for the difference between the two groups The lower limits are also greater than the -10% cutoff value, which further proves that the efficacy of contezolid and linezolid is comparable.
The overall incidence of post-treatment adverse events (TEAE) was comparable in the two groups of contezodamine and linezolid, and the TEAEs determined by the investigator to be related to the study drug were similar (23.4% vs 26.8%), most of which were mild Degree or moderate. However, the incidence of TEAEs related to study drugs in hematological examinations was lower in the contezodamine group than in the linezolid group: the proportion of patients with reduced white blood cell counts was 0.28% and 3.42%, respectively, and the neutrophil count The proportion of patients with reduced blood count was 0.28% and 1.71%, the proportion of patients with reduced reticulocyte count was 0.28% and 1.42%, and the proportion of patients with decreased platelet count was 0% and 2.28%, respectively. Of the 405 patients who were treated for more than 10 days, the proportion of patients with platelet counts that declined by more than 30% from baseline at the end of treatment (EOT) was 25.4% and 2.5%, respectively.
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