FDA approves new drug for excessive perspiration.
Run a mile in the heat of the summer and you may get a sense of what some people with excessive sweating deal with every day.
Fortunately, there will soon be a new treatment option available.
The FDA recently approved Qbrexza (glycopyrronium), a once-daily topical treatment, for primary axillary hyperhidrosis (excessive underarm sweating).
Last month, the pharmaceutical company Dermira received the approval based on results from two Phase 3 clinical trials that evaluated the drug’s safety and efficacy.
“For years, dermatologists have been telling us of the need for new treatment options that address primary axillary hyperhidrosis, given the stigma and burden associated with this condition,” said Tom Wiggans, chairman and chief executive officer at Dermira, in a press release.
Qbrexza is a topical treatment towelette meant for a single daily use and is approved in patients nine years of age and older. The method through which Qbrexza works is novel and noninvasive.
It is an anticholinergic, which means it blocks certain neurotransmitters in the central and peripheral nervous system. When applied to the skin, Qbrexza blocks sweat production by inhibiting activation of the sweat glands.
Side effects of Qbrexza include dry mouth, headache, blurred vision, and dry skin. More serious effects can include worsening urinary retention and problems regulating body temperature. Because sweating is essential to regulating the body’s temperature, patients using Qbrexza when it is hot may be prone to heat stroke.
And yes, excessive sweating is a real medical condition. It affects nearly 10 million people in the United States, occurring similarly in both men and women.
“This isn’t just a cosmetic condition. I’ve had patients that don’t want to go to their kids’ graduation because they are worried that they are going to sweat so much that they are going to sweat through their clothing or they can’t shake people’s hands because they are dripping,” said Dr. Michele S. Green, a board-certified dermatologist.
“Unless you’ve experienced it or seen patients who suffer from it, it may seem like it’s not a big deal to people, but it really is. A lot of people are just devastated by it,” she said.
Stigma around excessive sweating is a predominant reason that individuals seek out treatment in the first place.
Hyperhidrosis is divided into two categories: primary and secondary. Primary hyperhidrosis is not caused by another medical condition, nor is it caused by medication. Sweating tends to occur in specific focal areas, such as the underarms, hands, or feet. It is also generally symmetrical, meaning that sweating occurs on both sides of the body at the same time.
As noted above, these symptoms can result in impairment to daily activities, such as avoiding social interactions.
Secondary hyperhidrosis is typically caused by a medication. Unlike primary hyperhidrosis, sweating may occur on large areas of the body rather than specific focal points. Secondary hyperhidrosis symptoms also tend to occur when sleeping.
A list of drugs known to cause hyperhidrosis can be found here.
There are currently several treatment options available on the market, of which Qbrexza is the latest development. Antiperspirants are the most common, but can lead to stains and discoloration on clothing.
The use of Botox to treat excessive sweating is also common, but requires injections intermittently.
“Botox works, but it’s not 100 percent and we have to redo it every three to six months, depending on how much you are sweating. So, that’s not ideal for some patients because it’s expensive and they have to come back,” said Green.
Other options include lasers and microwave technology, such as miraDry, which was approved for use in the United States by the FDA in 2015.
But the ease of use of Qbrexza may give it an edge over other current leading treatments.
“With the FDA approval of Qbrexza, hyperhidrosis sufferers finally have a new medication option to help manage their excessive, uncontrollable sweating,” said Lisa J. Pieretti, executive director and co-founder of the International Hyperhidrosis Society.
“It was July 2004 when Botox was approved for underarm hyperhidrosis, so a new innovation has been a long time coming — and dearly needed by the entire community.”