U.K.-based BTG International submitted a new drug application to the FDA for a microfoam injection that treats varicose veins. BTG said it expects to hear whether the drug gains approval by the second quarter.
Varisolve, polidocanol endovenous microfoam (PEM), is unlike other treatments for the swollen, twisted veins because of its method of action. Its gas-filled bubbles, uniformly dense, are designed to chemically scar the inner tissue of varicose veins, a treatment called sclerotherapy. The liquid treatments used previously are more quickly deactivated and diluted by blood frequency, whereas the foam stays viable with lower concentrations of polidocanol, the active ingredient.
Sclerotherapy involves the scarring of the inside of the veins to close them off and restrict blood flow. As a treatment for varicose veins, it has been used since 1851 with the advent of hypodermic needles, according to the National Institutes of Health.
Varicose veins, which affect up to 25% of the Western adult population, according to the NIH, can simply be an aesthetic problem, or they can lead to more severe cases, including painful venous leg ulcers. The National Heart, Lung, and Blood Institute references several treatments, including laser surgery, ablation therapy and surgical removal of the veins.
Results of the U.S. Phase III trial of PEM in 2012 showed "a high degree of statistical significance," according to BTG. In an earlier European Phase III trial, 90% of patients exhibited symptoms at three months and less than 10% at one year. Also, unlike surgical methods, PEM treatment allowed for simpler application and recovery.
- here's the release