The US Food and Drug Administration (FDA) has approved polidocanol injectable foam (Varithena, BTG) for the treatment of incompetent veins and visible varicosities of the great saphenous vein (GSV) system, British pharmaceutical company BTG announced today.
Varithena (formerly known as Varisolve) is a pharmaceutical-grade, low-nitrogen, polidocanol foam dispensed from a proprietary canister device. It is a “minimally invasive, non-surgical procedure that requires neither tumescent anesthesia nor sedation,” the company said in a news release.
In a pair of phase 3 placebo-controlled studies known as VANISH-1 and VANISH-2, polidocanol injectable foam led to clinically meaningful improvement in the symptoms of superficial venous incompetence and the appearance of visible varicosities and addressed the underlying venous incompetence in the majority of patients treated, the company said.
It is estimated that more than 30 million adults in the United States have varicose veins, with women twice as likely as men to develop varicosities. Varicose veins may require treatment for symptoms including leg pain, aching, heaviness, restless legs, cramps, throbbing, fatigue, itchiness, tingling, and edema. Current treatments for varicose veins include thermal ablation and surgery.
Polidocanol injectable foam “provides US physicians with the only approved comprehensive therapy to improve symptoms and appearance for a wide range of varicose veins, including incompetent GSV, accessory saphenous veins and visible varicosities of the GSV system both above and below the knee,” BTG said.
According to the release, the company plans to launch the product in the second quarter of 2014.
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