Brickell Biotech Inc.(‘ Brickell’) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing novel and specialized prescription therapies for the treatment of debilitating skin diseases, today announced the Kaken Pharmaceutical Co., its development partner. A new drug application for approval of manufacturing and marketing of sofpironium bromide in Japan for primary axillary hyperhidrosis was submitted by Ltd. (“Kaken”) The sofpironium bromide application in Japan includes data from the Japanese Phase 3 trial, targeting patients with primary axillary hyperhidrosis, in which positive results were obtained.
Sofpironium bromide, is a proprietary new molecular entity which belongs to a class of anticholinergic medications. Anticholinergics inhibit the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a variety of bodily functions including sweat gland activation. Sofpironium bromide was engineered with retrometabolism. Retrometabolic drugs are designed to exert their action topically and, once absorbed into the blood, are potentially quickly metabolized into a considerably less active metabolite. The proposed action mechanism can allow the use of highly effective doses while minimizing systemic side effects. Sofpironium bromide was discovered by Dr. Nicholas Bodor at Bodor Laboratories, Inc.
Hyperhidrosis is a life-changing medical condition in which a person sweats more than the body needs to control his or her temperature. It is estimated that more than 15 million people, or 4.8 per cent of the U.S. population, suffer from hyperhidrosis. Axillary (underarm) hyperhidrosis is the intended first indication for sofpironium bromide and is the most common occurrence of hyperhidrosis, affecting an estimated 65 percent of patients or 10 million individuals in the United States. Doolaugh et al. Arch Res Dermatol (2016).
Brickell Biotech, Inc. is a pharmaceutical clinical-stage company focused on developing novel and specialized drug treatments for the treatment of chronic skin conditions. Brickell’s pipeline consists of possible new hyperhidrosis treatments, cutaneous T-cell lymphoma, psoriasis, and other common dermatological disorders.