YuYu Pharma’s treatment for osteoporosis, Maxmarvil, can help to prevent osteoporotic fracture and improve bone mineral density (BMD) of the lumbar spine and hip by 5 percent and 1.5 percent, respectively, the company said Wednesday.
YuYu유유제약 put Maxmarvil to market in 2005 as the world’s first new incrementally modified drug for osteoporosis. It contains only half dose (5mg) of alendronate and active vitamin D, calcitriol 0.5㎍. It won the U.S. patent by adding enteric coated tablet which dissolves in the intestines rather than the stomach to an enhancer.
The phase IV clinical trial results of Maxmarvil appeared in the May issue of the Journal of Bone Metabolism, an English journal published by the Korean Society for Bone and Mineral Research. It was a multicenter observational study conducted for five years, assessing the fracture-preventing efficacy and safety on 848 patients with osteoporosis.
Osteoporosis patients of 50 or older were participating in this study and followed up the incidence of osteoporotic fracture and change of BMD for one year. Also, the company conducted the analysis of high-risk patients who had a history of fracture.
|This graphic shows the changes in bone mineral density of lumber spine and hip before and after the treatment with Maxmarvil for one year.|
After a 12-month follow-up of patients treated with Maxmarvil, osteoporotic fracture occurred in 2.7 percent of subjects and BMD of the lumbar spine and hip improved by 5 percent and 1.5 percent, respectively.
This study surveyed the difference of mobility, self-care, usual activity, pain/discomfort and anxiety/depression before and after the treatment of Maxmarvil. The percentage of patients who responded as Level 3 (serious) decreased from 16.3 percent to 4.2 percent in mobility, from 17.9 percent to 5.2 percent in self-care, from 19.1 percent to 6.1 percent in usual activity, from 16.3 percent to 4.8 percent in pain/discomfort, and from 9.4 percent to 1.6 percent in anxiety/depression. This indicates that the quality of life in all domains improved statistically significant after the treatment of Maxmarvil.
“Treatment efficacy as seen by the improvement of BMD and fracture prevention was similar between the study of Maxmarvil in Korean patients and the study of alendronate 10mg in Western patients,” said Yoo Jun-il, study author, and professor of the department of orthopedic surgery, Gyeongsang National University Hospital.
The only approved dose for alendronate is 5 mg/day in Japanese patients whose body mass index (BMI) is similar to Korean patients, suggesting the most appropriate dose of alendronate for Koreans, he added.
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