Non-Alcohol Docetaxel Formula Awaits FDA Decision

Teikoku Pharma USA has submitted a New Drug Application to the FDA for the product.

Citing a critical need for a non-alcohol docetaxel formulation, Teikoku Pharma USA (TPU) has submitted a New Drug Application to the FDA for the product.

In June 2014, the FDA issued a warning about available docetaxel formulations, which contain alcohol, stating that they may cause patients to become intoxicated during and after treatment.

"Health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications,” the FDA wrote in the drug safety warning. “Consider a docetaxel formulation with the lowest possible alcohol content for patients who experience adverse reactions.”

The alcohol content of currently available docetaxel formulations ranges from 2 g to 6.4 g in a 200 mg dose, and manufacturers have revised the labels of their docetaxel products to reflect the FDA’s warning.

TPU’s non-alcohol docetaxel injection concentrate “offers an alternative to patients who might experience an adverse reaction to currently marketed docetaxel formulations due to alcohol sensitivity, and those who simply prefer an alcohol-free product,” stated TPU Executive Vice President and Chief Operating Officer Paul Mori in a press release.

Docetaxel is indicated to treat breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. TPU’s non-alcohol formula comes as 1 vial of docetaxel injection in 3 presentations: 20 mg/1 ml, 80 mg/4 mL, and 160 mg/8 mL.