How Realistic Is Injectable Tan/Sun Protection? UK Cracks Down On Illegals
This article was originally published in The Rose Sheet
UK regulators are warning consumers not to use Melanotan, an "injectable tan" being sold illegally online; however, a product in development by Australian firm Clinuvel raises the question of whether self-tanner and sun protection marketers could face competition down the road from such an injectable
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Melbourne, Australia firm Clinuvel Pharmaceuticals says FDA has granted Investigational New Drug status to its photoprotective afamelanotide drug, allowing it to initiate clinical trials in the U.S. A synthetic version of a naturally occurring hormone that controls melanin levels in human skin, Clinuvel's drug has achieved positive interim results in Switzerland in a Phase III trial involving subjects with a severe genetic skin disorder causing absolute intolerance to sun, according to a recent statement. The substance is in clinical studies in Europe and Australia for four other UV-light-related indications, and there is speculation that Clinuvel eventually could pursue the drug's use in healthy populations for aesthetic purposes; the company previously has reported that the tan associated with its product lasts for roughly three months (1"The Rose Sheet" Nov. 24, 2008, p. 4). In late 2008 UK regulators took action to stem the sale of similar, unlicensed Melanotan products promising an "injectable tan" due to potentially serious side effects. This year Clinuvel aims to "finalize" initial data related to afamelanotide use in cancer patients undergoing photodynamic therapy; it also intends to brand and settle on a trade name for its drug that currently goes by "CUV1647.
The European Chemicals Agency is working to develop a centralized, expedited authorization process to increase the availability of disinfectants to consumers and healthcare professionals fighting the novel coronavirus. Meanwhile, the ECHA encourages companies to work with national authorities on single-market applications for derogations under the Biocidal Products Regulation to speed up production.