Rexis® (500 μg/10 mL in vial) is an injectable drug product that provides the essential trace element, selenium, for the human body. Several early clinical studies have demonstrated that the administration of selenium via intravenous injection can reduce the mortality in patients with severe disease such as sepsis. In addition, it has been reported that selenium can increase the body’s anti-oxidant activity via GPx enzyme, and modulate humoral and cell-mediated immunity to maintain balanced immune function, thereby reducing the possibility of hospital-acquired infections.
The globally high mortality rate of sepsis is still not under effective control. Sepsis is particularly prevalent in immunocompromised patients, especially the elderly with declining immune system. Currently, most of the developed and developing countries are showing trends of population ageing, of which sepsis might cause a significant health threat. The phase III clinical trial (CARE-SEPS study) of Rexis® as an add-on therapy for sepsis patients, which was simultaneously conducted in seven medical centers in Taiwan, had been completed. Clinical data showed that the Rexis® injection was with good safety and tolerability. Although the primary endpoint of mortality was not met with statistical significance, there was evidence of selenium deficiency in most of the sepsis patients, and the patients could rapidly recover from the low selenium status and shorten hospitalization days after the administration of Rexis®. Our first marketed product, Zelnite®, is a low-dose selenium injection solution (100 μg/2 mL in ampoule). The phase III clinical data will be used for the application of post-approval changes in dosage and primary packaging component for Zelnite®, marketing a high-dose selenium injection solution (500 μg/10 mL in vial) is expected to expand clinical applications of patient population and meet the medical needs of the higher dosage.