Hans Hofland, Ph.D, and Dr. Steve Xu shine a spotlight on Dermira and its novel topical medicine indicated for primary axillary hyperhidrosis in patients 9 years of age and older.
Qbrexza is a novel topical medicine indicated for primary axillary hyperhidrosis in patients 9 years of age and older. (©PopPaulCatalinShutterstock.com)
Hans Hofland, Ph.D.
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.
Stiefel Laboratories acquired Connetics in 2006 charting a new path for the treatment. However, convincing the new commercial leadership organization of the value of the investigational compound proved diffcult.
“We knew the need existed based on conversations with dermatologists and patients but demonstrating that a market large enough to develop a therapy like this existed was initially challenging,” says Hans Hofland, Ph.D., vice president for research at Dermira and former researcher at Connetics. Glycopyrronium was tested in a small cohort of Australian patients yielding a positive result, in 2008, and a small dose finding phase 2b study was initiated in 2009, which also showed very promising results.
Stiefel was acquired by GlaxoSmithKline in 2009 thrusting the future development and commercialization of the therapy into question again.
“There was recognition by this time that hyperhidrosis was an underserved medical condition, but lingering, unfounded concerns over the safety of glycopyrronium prevented the program from continuing,” Dr. Hofland and says. The compound was effectively shelved for the next several years before Dermira stepped in to acquire the investigational therapy from the company with a plan to continue its development in 2014.
A new and improved form of the molecule was developed and a phase 2b study initiated in 2014. A year later, promising safety and efficacy results allowed the company to rapidly move to phase 3 testing. While the late-stage trials were underway, the company continued to research the prevalence of the condition and sought to further understand its impact on daily lives of patients. A number of prominent names in dermatology signed onto the phase 3 program and helped design trials that would not only confirm the therapy’s benefit, but also measure its impact on a patient’s quality of life before and after treatment. The lessons learned from the trials, which reported favorable results in 2016, would also serve as the foundation for planning efforts around a multi-channel disease state awareness campaign to raise awareness of the condition. The original vision of a single-use towelette offered patients an intuitive, e ective and elegant method of delivery.
When the treatment was finally approved in June 2018, it capped what was known around the halls of Dermira as a long-term passion project for innovation.
Today, more than 50,000 patients have received Qbrexza and just over 16,000 healthcare professionals have prescribed the therapy.