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Varisolve ®, the concept never died !!!
In the early 2005 FDA finally approved a generic version of the sclerosant drug, STS ( Sotradecol®, Bioniche Inc. ). This ended uncertainties clouding sclerotherapy practices that were faced with shortage of this drug. The launch of the branded STS is appreciated for assuring safety of sclerotherapy technique. The FDA approved STS is popular with phlebologist, but for technical reasons, (STS use , needs lot of training or could cause complications ) and its high cost is pushing the market to find alternatives. Varisolve ®, is a foamed version of the sclerosant drug “Polidocanol ” and had been in clinical development since 2001. Polidocanol, is a sclerosant drug similar in chemistry with STS, but has a better safety profile. Polidocanol has been tried in sclerotherapy for many years and is proven to be safe and effective. Varisolve, is a ready to use injection mixture of polidocanol solution and physiological gases. This bottled foam is very stable and has a “Tooth paste ” like consistency. This allows the drug to stay longer at the site of injection and produce maximal effect. The concept of the treatment is great, for it has the potential for treating the Greater Saphenous Vein (GSV) by a single injection. Few initial studies done in the Europe, have demonstrated efficacy in the range of 80-90 %. FDA had apparently put a hold on the Varisolve clinical studies in the US (in 2004), for the potential risk the drug had for precipitating stroke or heart attack { blood supply to the brain could be compromised ( stroke ) , if the air bubbles block the arterial supply to the heart ( heart attack ) } Imaging studies had found that, injected Varisolve in a peripheral vein could travel to the heart, especially to its left chambers, which are responsible for pumping oxygenated blood ( arterial blood ) to the vital organs .With this major setback, Provensis , the drug developer had stopped all operations in the US and had started testing newer versions of the drug in the Europe. After a year long study in 435 patients they have now, resubmitted the patient safety data to the FDA recently. FDA convinced by the European study results has now allowed the company to resume studies in the US. This enables Provensis to resume the drug development proces
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