Drug Name: Sofpironium bromide
R&D Code: BBI 4000
CAS : 1628106-94-4,2409055-48-5 (p-Toluenesulfonate)
Company: Botanix Pharmaceuticals
Availability: June 18, 2024
Indications:Primary axillary hyperhidrosis in children and adults over 9 years of age.
Trade name: Sofdra
Hyperhidrosis is excessive sweating. It occurs when the amount of sweating exceeds the amount your body needs to regulate your body temperature. You may sweat at rest, in cold weather, or randomly when you don't expect to. Sweat is an odorless fluid released from sweat glands. Sweat works to help regulate your body temperature and prevent overheating; hyperhidrosis is the result of overworked sweat glands.
Primary localized hyperhidrosis: Localized hyperhidrosis is a chronic skin condition. It is caused by a genetic change (mutation), which means that the disease runs in families. It is the most common type of hyperhidrosis. It usually affects the armpits, hands, feet and face. It tends to start before the age of 25.
Secondary generalized hyperhidrosis: Generalized hyperhidrosis is excessive sweating caused by an underlying medical condition or medication side effect. Generalized hyperhidrosis may cause the patient to sweat while sleeping.
There are approximately 10 million people with primary axillary hyperhidrosis in the United States.
FDA approval of Sofdra was based on the results of two pivotal Phase 3 “CARDIGAN” studies evaluating the efficacy and safety of Sofdra versus a carrier, which enrolled 701 patients with primary axillary hyperhidrosis.
