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The United States Food and Drug Administration (FDA) approved topic glycopyrronium ( Qbrexza Dermira) for the treatment of adults and children as young as 9 years of age who have hyperhidrosis axillary primary.
Qbrexza is a topical anticholinergic tissue applied to the armpits and designed to block the production of sweat by inhibiting the activation of the sweat glands.
The safety and effectiveness of Qbrexza for primary axillary hyperhidrosis were evaluated in two phase 3 clinical trials (ATMOS-1 and ATMOS-2). Both trials evaluated the absolute change in sweat production after treatment with Qbrexza, as well as the proportion of patients achieving an improvement of at least 4 points in relation to the severity of sweating measured by the Axillary daily newspaper. Sweating Daily (ASDD), exclusive property of Dermira. instrument of patient-reported results (PRO). The PRO was developed in consultation with the FDA and in accordance with the 2009 guidelines of the agency on PRO instruments
With Qbrexza, patients experienced a "notable and lasting reduction in their overall sweat production", announced the company. FDA approval.
Axillary hyperhidrosis, which affects nearly 10 million people in the United States, can hinder normal daily activities and lead to occupational, emotional, psychological, social, and physical disorders.
"Primary Axillary Hyperhidrosis is a Disease That" Dee Anna Glaser, MD, Professor and Acting Chair of the Department of Dermatology at the School of Medicine at the University of St. Louis, Missouri , has had an impact on many of my patients for most of their lives. "I anticipate with anticipation that Qbrexza's potential is a significant treatment option that will not only reduce sweating but will reduce the risk of death." general impact of this condition on their daily life. "
The most common adverse events observed 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 hesitancy (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 or burning (14.1%) and pruritus (8.1%) were also common.
Qbrexza is contraindicated in patients with conditions 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 Sjogren's syndrome). Qbrexza should be used with caution in patients with a history or presence of documented urinary retention. Complete prescription information is available online.
The company expects Qbrexza to be available in pharmacies across the country from October
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