FDA releases guidelines for the development of botulinum toxin products

The Food and Drug Administration(FDA) has released draft guidelines on how best to develop botulinum toxins, specifically for products that target wrinkles in the upper facial region.

According to the FDA the purposeof the guidance – UpperFacial Lines: Developing Botulinum Toxin Drug Products – is to assist manufacturers in the clinical development of botulinum toxins for the temporary improvement of upper faciallines, such as glabellar orlateral canthal (LCLs).

They said that the guidelines, developed by the Division of Dermatology and Dental Products at the FDA, are, “intended to serve as a focus for continued discussions among the Division ofDermatology and Dental Products,pharmaceutical sponsors, the academic community, and the public.” Concerning the planning and development of clinical trials, the FDA suggested that manufacturers shouldaddress concerns such as inadvertentinjection, unintended mucosal exposure,and unintended transfer of the drugproduct. Two adequate and well-controlledtrials into the safety and efficacy of the botulinum toxins were advised bythe FDA, and it is recommended that the trial population shouldbe representative of the audience that the product is targeted towards.

“Botulinum toxin drugproducts present a uniqueset of safety concerns related to thepotential for local and distant spread oftoxin effect,” said the guidelines. Adding,“Drug products for the temporaryimprovement of upper facial lines have the potential for chronic intermittent use; therefore sponsors should establish the long-term safety of the drug product in the proposed population at the proposed dose.”