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FDA Approves First Drug Made to Reduce Excessive Sweating

New Treatment for Excessive Underarm Sweating 

Orange County, CA - June 6th, 2018 -  Primary axillary hyperhidrosis, also known as Excessive Underarm Sweating, affects an estimated 15 million people in the United States, according to a study. Of the 15 million, 65 percent of people suffer from localized sweating to the underarms (axillary disease).

The body’s mechanism for cooling itself is overactive, meaning people sweat five times more than what is necessary. Studies have shown that excessive sweating hinders regular daily activities, and can result in emotional, psychological, social, and physical impairment. 

Most people are never diagnosed or relieved of their symptoms. The Treatment options are currently surgery, Botox injections, and off-label use of drugs that block the body’s chemical messengers.

Dermira, a Silicon Valley firm, has won the U.S. Food and Drug Administration’s (FDA) approval for the first once-daily, topical prescription treatment named “Qbrexza”. It is indicated for adult and pediatric patients (9 years of age and older) who suffer from Excessive Underarm sweating.

The approval is based on the results of two Phase 3 clinical trials, ATMOS-1 and ATMOS-2, which evaluated the efficacy and safety of Qbrexza in patients with primary axillary hyperhidrosis. Both trials demonstrated a significant improvement for both co-primary endpoints and both secondary endpoints.

The most frequently reported side effect was dry mouth. Other possible side effects include dryness of the skin, eyes, nose, and throat; with possible headaches, blurred vision, dilated pupils, constipation, or trouble urinating. 

The treatment comes in the form of a cloth soaked in glycopyrronium, an anti-cholinergic, which is a chemical that blocks receptors that help activate sweat glands. The treatment doesn’t need to be administered by a physician. Once prescribed, it's up to the patient to apply the treatment one time, each day.

Qbrexza is expected to be available nationwide in pharmacies beginning in October 2018.

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About Ampronix

Ampronix is a renowned authorized master distributor of the medical industry's top brands as well as a world-class manufacturer of innovative technology. Since 1982, Ampronix has been dedicated to meeting the growing needs of the medical community with its extensive product knowledge, outstanding service, and state-of-the-art repair facility. Ampronix prides itself on its ability to offer tailored, one-stop solutions at a faster and more cost-effective rate than other manufacturers. Ampronix is ISO 13485:2003, and ANSI/ESD S20.20-2014 certified.

 



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FDA Approves First Drug Made to Reduce Excessive Sweating

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