Boryung said it launched Korea's first alcohol-free docetaxel liquid anticancer drug, Ditaxel Inj., for the treatment of breast cancer.

First launched in 2012, Ditaxel is a taxane-based anticancer drug used to treat breast cancer and has a wide range of indications, including non-small cell lung cancer, prostate cancer, ovarian cancer, head and neck cancer, stomach cancer, and esophageal cancer.

The new product replaces ethanol, an additive in the existing docetaxel product, with another additive, which can reduce symptoms caused by the alcohol component.

The main ingredient of docetaxel is not very soluble in water, so many companies that manufacture the drug add ethanol during the manufacturing process to compensate for this.

As a result, there is a risk of ethanol-induced symptoms similar to those caused by drinking alcohol when taking docetaxel, as each milliliter of docetaxel contains approximately 0.5 milliliters of ethanol additive.

The FDA also issued a warning in 2014 that the presence of ethanol in docetaxel could cause patients to experience alcohol intoxication or feel intoxicated during and after treatment, and a Korean study found that 44.3 percent of patients receiving docetaxel products reported ethanol-related symptoms, including hot flashes, nausea, and dizziness.

Due to this risk of side effects, alcohol-free products have already been developed and prescribed in the U.S. and Japan.

As there was an unmet medical need for alcohol-free docetaxel in Korea, Boryung started developing a product that replaced the alcohol component, and after four years of research and development, the company obtained a change permit from the Ministry of Food and Drug Safety on Tuesday.

According to the company, despite being alcohol-free, Ditaxel is a product that improves stability by using a high-purity solvent, and a composition patent has also been registered.

"Ditaxel is the only alcohol-free docetaxel liquid formulation in Korea that can reduce various symptoms caused by alcohol during docetaxel administration," Boryung Onco Division Head Kim Young-suk said. "We will continue to do our best to develop differentiated products that can improve therapeutic outcomes by carefully considering the patient's treatment process."