Miami, FL, June 25, 2024 – Bodor Laboratories Inc., a leading pharmaceutical research and development company, is pleased to announce that its licensee, Botanix, an Australia- and Pennsylvania-based pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for SofdraTM (sofpironium) topical gel, 12.45% for the treatment of primary axillary hyperhidrosis (excessive underarm sweating). With this approval, Bodor Laboratories is set to receive a milestone payment, in addition to ongoing sales-based royalties from Botanix.
Sofpironium bromide, designed by Dr. Nicholas Bodor, is a safe anticholinergic agent with multiple therapeutic potentials. Initially licensed to Brickell BioTech in 2012 for the development of hyperhidrosis treatments, the rights were acquired by Botanix in 2022. Botanix completed the development, leading to the recent FDA approval. Sofpironium bromide is the first and only new chemical entity approved in the U.S. for the treatment of primary axillary hyperhidrosis in adults and children 9 years of age and older.
Previously approved in Japan in 2020 as ECCLOCK® Gel 5%, the product has enjoyed robust sales and continues to make significant market impacts. Bodor Laboratories owns extensive worldwide patent coverage, with ongoing development efforts aimed at bringing this innovative treatment to other global regions.
Dr. Erik Bodor, CEO of Bodor Laboratories, commented, “The FDA approval of SofdraTM marks a significant milestone in the innovative drug design pioneered by our company. The creation of the soft anticholinergic class, represented by sofpironium bromide, showcases our commitment to developing safe and effective treatments. We are excited to see the successful sales and marketing efforts by Botanix, which will begin generating revenue later this year.”
Bodor Laboratories Inc. is a pioneering privately held pharmaceutical research and development company founded in 2006 inspired by and based on Dr. Nicholas Bodor’s visionary Retrometabolic Drug Design (RMDD) concepts. This groundbreaking approach has been instrumental in the development of several revolutionary drugs, including highly successful therapies based on two molecules invented personally by Dr. Bodor: loteprednol etabonate (ALREX®, LOTEMAX®, ZYLET®, INVELTYS®, EYSUVIS®) and sofpironium bromide (ECCLOCK®, SOFDRATM). With a steadfast commitment to advancing the field of medicine by employing drug design strategies that simultaneously increase both effectiveness and safety, Bodor Laboratories remains at the forefront of pharmaceutical research and development. We continuously harness the power of RMDD concepts to propel our pursuit of creating innovative therapeutics with the potential to transform lives.
Our pipeline is built upon the foundation of existing approved therapies, which we are expanding to address a wide range of disease states, such as sialorrhea, COPD, and myopia. In addition to advancing the development of the soft anticholinergic class of molecules, exemplified by sofpironium bromide, we are also exploring the potential of a new generation of soft steroids to build upon the success of loteprednol etabonate.
For comprehensive information about Bodor Laboratories Inc., our innovative research and diverse pipeline, please visit www.bodorlaboratories.com or contact Elvie Guy at [email protected].