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FDA OKs New topical treatment for excessive sweating of the forearms



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

Qbrexza is a topical anticholinergic cloth that is applied to the underarms to prevent sweat production by inhibiting sweat gland activation.

The safety and efficacy of Qbrexza for primary axillary hyperhidrosis has been investigated in two phase 3 clinical trials (ATMOS-1 and ATMOS-2). Both studies assessed the absolute change in sweat production after treatment with Qbrexza from baseline, along with the proportion of patients who were at least 4 points above baseline in DTS, as measured by Dermira's Axillary Sweating Daily Diary (ASDD) Patient reported outcome (PRO) instrument. The PRO was developed in consultation with the FDA and in accordance with the Agency's 2009 PRO Instruments Guidelines.

With Qbrexza, patients experienced a "noticeable and sustained reduction in their total sweat production," the company said in a press release with FDA approval.

Axillary hyperhidrosis, which affects nearly 1

0 million people in the US, can interfere with normal day-to-day activities, leading to occupational, emotional, mental, social, and physical impairments.

"Primary axillary hyperhidrosis is a condition that is negative Many of my patients have been affected for most of their lives," said Dee Anna Glaser, MD, a professor and preliminary chair, department of dermatology at the Saint Louis University School of Medicine, Missouri, in the release. "I look forward to the potential of Qbrexza to be a viable treatment option that not only reduces a person's sweat, but also reduces the overall impact of this condition on their daily lives."

The most common adverse reactions 2% of Qbrexza-treated patients were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), Urinary retardation (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 / burning (14.1%) and itching (8.1%) were also common.

Qbrexza is contraindicated in patients with medical conditions that may be exacerbated by anticholinergic activity Qbrexza (eg, glaucoma, paralytic ileus, unstable cardiovascular status in acute bleeding, severe ulcerative colitis, toxic megacolon that complements ulcerative colitis, Myasthenia gravis and Sjögren syndrome). Qbrexza should be used with caution in patients with a history or proven urinary retention. Full prescribing information is available online.

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

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