Kuhnil Pharmaceuticals said Tuesday that it has succeeded in phase 3 clinical trial for its new Atorvastatin soft capsule (Original: Lipitor).
Atorvastatin is a dyslipidemia treatment combination used primarily as a treatment for lowering lipid and preventing events associated with cardiovascular disease.
In the phase 3 trials, 215 patients, who were adequately controlled for low-density lipoprotein cholesterol but not for triglycerides, were treated by the company’s Atorvastatin soft capsule by 38 clinical institutes such as Samsung Medical Center 서울삼성병원.
The clinical trial results showed that the primary efficacy endpoint non-HDL-c significantly dropped in the combination therapy group versus the atorvastatin monotherapy group, while secondary efficacy endpoints such as triglyceride and total cholesterol were also found to have significantly decreased.
The company’s 건일제약 new Atorvastatin soft capsule, which comes after the Rosuvastatin soft capsule (Original: Crestor) approved by the Ministry of Food and Drug Safety (MFDS) on July 31, used the company’s patented technology.
The technology allowed Atorvastatin to be coated on top of the Omega-3 Soft Capsule while maintaining the stability and size of the capsule.
Unlike traditional combination products, the prospect of the treatment entering the markets of advanced countries is high, given that it overcame the two sensitive APIs with unique formulation technology and clinically proven superiority over single agents.
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