PharmGen Science is set to make a significant entry into the cardiovascular treatment market with the official launch of its new combination therapy for mixed dyslipidemia, Tabapheno Extended-Release Tablets, on May 1, the company announced on Thursday.
Tabapheno Extended-Release Tablets combine 2 mg of Pitavastatin Calcium and 178.8 mg of Fenofibrate Choline. The drug is approved for adult patients at high risk of coronary heart disease (CHD) who have well-controlled LDL-C levels but high triglycerides and low HDL-C levels.
Dyslipidemia is a condition where blood lipid components, including cholesterol and triglycerides, are outside the normal range. It typically manifests as high levels of low-density lipoprotein (LDL-C), low levels of high-density lipoprotein (HDL-C), and elevated triglycerides (TG).
The treatment paradigm has recently shifted from focusing solely on LDL-C control to a more comprehensive approach that includes managing triglycerides (TG) and HDL-C levels. This shift has increased the demand for combination therapies like statins and fenofibrate.
Tabapheno Extended-Release Tablets are designed to address multiple lipid abnormalities simultaneously. The drug combines Pitavastatin, which effectively controls LDL-C, with Fenofibrate, known for its ability to reduce TG and improve HDL-C levels.
The new formulation overcomes longstanding limitations of traditional fenofibrate products, such as poor absorption and the inconvenience of post-meal dosing. By incorporating choline salt into the fenofibrate, the drug’s solubility is enhanced. Phase 1 clinical trials have shown no significant differences in efficacy between pre- and post-meal administration.
Tabapheno Extended-Release Tablets also boast a unique formulation. Unlike existing combination therapies that often come in capsule form, this new drug is developed as a tablet, significantly reducing its size.
A spokesperson for PharmGen Science stated that Tabapheno Extended-Release Tablets represent a breakthrough in improving treatment convenience and adherence for patients with mixed dyslipidemia. It aims to rapidly expand the market share based on this product’s distinctive competitive advantages.
It’s important to note that medication responses can vary between individuals. Patients are advised to consult with their healthcare providers to ensure appropriate use of this or any medication.