Topical drugs are essential in the management of skin diseases. For instance, the World Health Organization lists 18 topical drugs in dermatology as part of their Essential Medicines list. While topical medications account for more than $167 billion U.S. dollars in global spending, breakthrough innovation in topical medicines lags behind the global pharmaceutical industry. Fundamentally, creating effcacious, safe and cosmetically elegant topical medicines is hard.
There are broader market forces such as lower economic return and lack of surrogate endpoints (thus dependency on subjective scales) that disincentivize investment in this space. Dermira (NASDAQ: DERM) is a biopharmaceutical company dedicated to developing novel therapeutics in medical dermatology. This month, we’ll examine a novel topical medicine indicated for primary axillary hyperhidrosis in patients 9 years of age and older.
When Qbrexza (glycopyrronium) was approved by the U.S. Food and Drug Administration in June 2018 for patients nine years and older with primary axillary hyperhidrosis or excessive underarm sweating, few people realized the nearly 15-year odyssey it took to come to market.
Primary axillary hyperhidrosis affects 10 million people in the United States; affects men and women equally; and it often presents in adolescents. Prior to its availability, dermatologists frequently used a combination of unapproved drug therapies or device technologies in an effort to minimize or eliminate sweating. In some instances, patients resorted to surgical procedures such as having sweat glands removed or the nerves associated with sweating cut, often with varying results.
In 2005, Connetics acquired the rights to this novel treatment idea. Researchers sought to develop a new product that would provide a person relief from their excessive sweating throughout the day. The company eventually developed a single-use towelette based on a simple, safe, fast-drying and easy-to-apply ethanol-based formulation.