PurTox is a new brand of non-surgical, cosmetic treatment for facial wrinkles, folds, and creases. It has yet to be approved by the Food and Drug Administration (FDA), but is expected to be available in late 2012. It is administered by injection, and will be approved based on use for the glabellar region, or treating frown lines, although the off-label usage may be similar to Botox in treating various other areas of facial wrinkles.
PurTox VS Botox: Similarities
PurTox is an injectable form of botulinum toxin type A, as is Botox, and its efficacy, safety, and longevity appear to be very similar to Botox in initial studies conducted. Both Botox and PurTox were developed by University of Wisconsin researchers. Repetitive muscle contraction is a major cause of permanent wrinkles forming in the facial area, and the primary function of both PurTox and Botox are to temporarily block the nerve signals, causing muscles in the face to contract.
From studies already completed, in the attempt to receive FDA approval, PurTox has indicated some of the same side effects exhibited by Botox. The patient may experience swelling, bruising, pain, ptosis (drooping of the eyelid) and redness at the site of injection. Because it is a drug made from botulinum toxin A, the same severe side effects are also possible, as in Botox. It is a toxin, being injected into the body, so there is always a risk of infection, or botulism symptoms to occur.
PurTox VS Botox: Differences
PurTox has been termed the naked botulinum toxin type A, because it does not have a hemagglutinin protein complex surrounding it. This gives PurTox the pure name, because with a higher concentration of human serum albumin, and without the surrounding complex proteins, it is a purer form of the toxin, and appears to exhibit a faster onset after injection than Botox. PurTox also claims to have fewer antigens, which lessens the body’s resistance to the product.
PurTox is manufactured by Mentor Corporation, and the company claims that PurTox is unique to Botox in that it is a purer form of botulinum toxin type A, it may be able to treat a slightly larger area of wrinkles, and it may also last longer. Until all research studies have been concluded and reviewed however, the claims cannot be legitimately verified.
Clinical Trial Results
Phase 3C of the clinical trials, involving 600-700 patients and twelve centers has been completed as of April, 2011, and the data gathered is used to support filing Mentor Corporation’s Biologies License Application (BLA) with the United States FDA, in order to receive approval for consumer use of PurTox. The studies injected either PurTox or a placebo of saline into the patients, and researchers analyzed a stringent rating system of the drug, and also high-resolution photographs independently, looking for pore size, wrinkles, longevity, and onset data, among other factors.
Dr. Brian Kinney, a renowned reconstructive plastic surgeon, and assistant professor of plastic surgery at the University of Southern California indicated that the patients were satisfied with the results of PurTox injections, with few side effects, and there were favorable early results. When it is approved by the FDA, PurTox may be a major competitor of Botox and Dysport.
Because Botox has generally had a monopoly on temporary wrinkle reduction, Allergan has been able to inflate prices, creating bargain Botox sales. This, along with poor Botox procedures being practiced, has led to the formation of a newer product. Do not be surprised to see marketing efforts directed to distinguish various enhanced nuances of each product, and variable prices. All data has yet to be confirmed by clinical trials, but if PurTox is effective sooner, lasts longer, and has fewer side effects, it may just give Botox some steep competition.