FDA approves treatment for underarm sweating

Aug 08, 2018, 12:00am

In June, Dermira Inc. announced the FDA approval of Qbrexza (glycopyrronium) for primary axillary hyperhidrosis ― excessive underarm sweating.

In June, Dermira Inc. announced the FDA approval of Qbrexza (glycopyrronium) for primary axillary hyperhidrosis ― excessive underarm sweating.

It is the first FDA-approved topical for this condition and may be available as a prescription treatment for pediatric and adult patients later this year.

Primary axillary hyperhidrosis affects nearly 10 million people in the U.S., affecting men and women equally. Qbrexza is an anticholinergic that comes as a cloth designed to be applied once-daily to the affected area. It works by inhibiting the activation of sweat glands.

It's approval is based on results from two phase three clinical trials, ATMOS-1 and ATMOS-2, which evaluated the efficacy and safety of Qbrexza in patients with primary axillary hyperhidrosis. Both trials assessed the absolute change from baseline in sweat production (the weight or amount of sweat a patient produced) following treatment with Qbrexza and the proportion of patients who achieved at least a four-point improvement from baseline in their sweating severity, as measured by the Axillary Sweating Daily Diary (ASDD), Dermira’s proprietary patient-reported outcome (PRO) instrument.

The most common adverse reactions seen in ≥2% of subjects treated with Qbrexza were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation (3.5%), vision blurred (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%), also occurred.

CONTRAINDICATIONS

Qbrexza is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Qbrexza, such as glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis and Sjogren’s syndrome.

PRECAUTIONS

Patients with urinary retention, or a history of urinary retention, may experience worsening symptoms with this treatment.
Because anticholinergics are designed to block sweat production, it may affect the body's ability to control temperature. Patients may experience heat illness in high temperature environments. Problematic signs include a lack of sweating in hot or very humid conditions and when these occur, it is advised to avoid using the product under these conditions.