BTG plc announced that the FDA has approved Varithena (polidocanol injectable foam) for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system. Varithena was formerly known as Varisolve PEM.
Polidocanol is a sclerosing agent that locally damages the endothelium of blood vessels. When injected intravenously, polidocanol induces endothelial damage.
Platelets then aggregate at the site of damage and attach to the venous wall. The occluded vein is then replaced with connective fibrous tissue.
The FDA approval was based on two Phase 3 placebo-controlled trials, VANISH-1 and VANISH-2. In both trials, Varithena achieved a clinically meaningful improvement in the symptoms of superficial venous incompetence and the appearance of visible aricosities.
Varithena is supplied in a convenience box that contains: one canister containing Polidocanol solution 180mg/18mL, one canister containing pressurized oxygen at 5.4 bar absolute, three Varithena transfer units, and three administration boxes.
Once activated, Varithena injectable foam delivers a 1% polidocanol solution. Each mL of Varithena injectable foam contains 1.3mg of polidocanol. Varithena is expected to launch in the 2nd quarter of 2014.
For more information call (877) 626-9989 or visit Varithena.com.