FDA Approves Topical Hyperhidrosis Treatment

The US Food and Drug Administration has approved Qbrexza (glycopyrronium), an anticholinergic cloth for the topical treatment of primary axillary hyperhidrosis in adults and children aged 9 years and older.

The approval was granted after the success of 2 phase 3 clinical trials—ATMOS-1 and ATMOS-2. Both trials evaluated the absolute change from baseline in sweat production with Qbrexza use and determined the proportion of patients who achieved at least a 4-point improvement from baseline on the Axillary Sweating Daily Diary instrument.

The most commonly reported side effects with Qbrexza use included dry mouth, mydriasis, oropharyngeal pain, headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin, and constipation. Erythema, burning/stinging, and pruritus were the most commonly reported local skin reactions.

Patients with medical conditions that can be exacerbated by the anticholinergic effect of Qbrexza should not use Qbrexza.

—Christina Vogt

Reference:

Dermira receives FDA approval for Qbrexza™ (glycopyrronium) cloth to treat primary axillary hyperhidrosis [press release]. Menlo Park, CA. June 29, 2018. http://investor.dermira.com/phoenix.zhtml?c=253686&p=irol-newsArticle&ID=2356602 Accessed on July 2, 2018.