FDA OKs New Topical Treatment for Excessive Underarm Sweating

Megan Brooks

Disclosures

June 29, 2018

The US Food and Drug Administration (FDA) has approved topical glycopyrronium (Qbrexza, Dermira) for the treatment of adults and children as young as age 9 years who have primary axillary hyperhidrosis.

Qbrexza is a topical anticholinergic cloth applied to the underarms and designed to block sweat production by inhibiting sweat gland activation.

The safety and efficacy of Qbrexza for primary axillary hyperhidrosis were evaluated in two phase 3 clinical trials (ATMOS-1 and ATMOS-2). Both trials assessed the absolute change from baseline in sweat production after treatment with Qbrexza, along with the proportion of patients who achieved at least a 4-point improvement from baseline in sweating severity as measured by the Axillary Sweating Daily Diary (ASDD), Dermira's proprietary patient-reported outcome (PRO) instrument. The PRO was developed in consultation with the FDA and in accordance with the agency's 2009 guidance on PRO instruments.

With Qbrexza, patients experienced a "noticeable and sustained reduction in their overall sweat production," the company said in a news release announcing FDA approval.   

Axillary hyperhidrosis, which affects nearly 10 million people in the United States, can impede normal daily activities and result in occupational, emotional, psychological, social, and physical impairment.

"Primary axillary hyperhidrosis is a condition that has negatively impacted many of my patients for most of their lives," Dee Anna Glaser, MD, professor and interim chair, Department of Dermatology at Saint Louis University School of Medicine, Missouri, said in the release. "I look forward to Qbrexza's potential to be a meaningful treatment option that will not only reduce a person's sweat, but will reduce the overall impact this condition has on their daily life."

The most common adverse reactions, seen in at least 2% of patients treated with Qbrexza, were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation (3.5%), blurred vision (3.5%), nasal dryness (2.6%), dry throat (2.6%), dry eye (2.4%), dry skin (2.2%), and constipation (2.0%). Local skin reactions, including erythema (17.0%), burning/stinging (14.1%), and pruritus (8.1%), were also common.

Qbrexza is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Qbrexza (eg, glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, and Sjögren syndrome). Qbrexza should be used with caution in patients with a history or presence of documented urinary retention. Full prescribing information is available online.  

The company expects Qbrexza to be available in pharmacies nationwide beginning in October.

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