Thein adults and children aged 9 years and older.
Glycopyrronium, which is formulated in a cloth wipe, will be marketed as Qbrexza and is expected to be available in October, according to the approvalJune 29, which was made by Dermira, the manufacturer. The instructions for use section in the states that patients are advised to use one cloth to apply the medication to both axillae, wiping the cloth across each underarm. Each cloth, intended for single use, is pre-moistened with 2.4% glycopyrronium solution.
Glycopyrronium blocks sweat production “by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation,” the company said in a February.
The approval was based on the results of two phase 3 clinical studies, ATMOS-1 and ATMOS-2, which were multicenter, randomized, double-blind, vehicle-controlled, 4-week studies in patients 9 years of age or older with primary axillary hyperhidrosis for 6 months or longer. Study subjects had production of at least 50 mg of underarm sweat over 5 minutes, and scores of four or higher on the 11-point Axillary Sweating Daily Diary (ASDD) or the Children’s ASDD (ASDD-C) – an instrument developed by the company in consultation with the FDA – and scores of three or four on the four-grade. In total, 463 patients were randomized to receive glycopyrronium and 234 to vehicle. Forty four of these patients were aged 9-16 years, with 25 receiving glycopyrronium and 19 receiving vehicle.
According to the February release, the ASDD/ASDD-C severity scale responder rates were about 60% in the pediatric and adult groups treated with glycopyrronium, compared with 13.0% and 28.8% for children and adults, respectively, in the vehicle group. At week 4, the median absolute change in sweat production was a reduction of 64.2 mg in children and a reduction of 80.6 mg among adults treated with glycopyrronium, compared with reductions of 53.7 mg and 62 mg among those in the vehicle group, respectively.
In the glycopyrronium-treated group, almost 80% of the pediatric patients and 74.3% of the adults experienced at least a 50% reduction in sweat production at week 4, compared with almost 55% and 53%, respectively, in the vehicle group.
Among pediatric patients, the mean decrease from baseline in the8.1 in glycopyrronium-treated patients, compared with 1.9 in the vehicle group. In adults, scores on the measure were reduced by 8.4 and 4.7 in glycopyrronium- and vehicle-treated adult patients, respectively.
Nearly 57% of adults and 44% of pediatric patients treated with glycopyrronium experienced treatment-emergent adverse events, compared with 34.3% of adults and 10.5% of the pediatric patients in the vehicle group. The majority were related to anticholinergic activity and were mild, and rarely led to drug discontinuation, according to the company.
The press release announcing the approval stated that the most common adverse effects observed after application of glycopyrronium were dry mouth, mydriasis, sore throat, headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin and constipation. Erythema, burning/stinging, and pruritus were the most common skin reactions.
The product is contraindicated in patients with glaucoma, paralytic ileus, and other medical conditions that can be exacerbated by its anticholinergic effects, according to the prescribing information. Patients should be advised that they should wash their hands thoroughly after application, and that it can cause temporary dilation of the pupils and blurred vision if glycopyrronium comes into contact with their eyes.