|Dermira Receives FDA Approval for Qbrexza™ (glycopyrronium) Cloth to Treat Primary Axillary Hyperhidrosis|
Primary axillary hyperhidrosis, also commonly known as excessive underarm sweating, is a chronic medical skin condition that results in sweating beyond what is needed for normal body temperature regulation. The exact cause is unknown, but it affects nearly 10 million people in
“For years, dermatologists have been telling us of the need for new treatment options that address primary axillary hyperhidrosis given the stigma and burden associated with this condition,” said
The approval is based on results from 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 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 PRO was developed in consultation with the
“Primary axillary hyperhidrosis is a condition that has negatively impacted many of my patients for most of their lives,” said
The most common side effects observed following topical application of Qbrexza to the underarms were dry mouth, dilated pupil (mydriasis), sore throat (oropharyngeal pain), headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin and constipation. The most common local skin reactions were erythema, burning/stinging and pruritus.
Qbrexza is expected to be available nationwide in pharmacies beginning in
About Qbrexza™ (glycopyrronium) cloth
IMPORTANT SAFETY INFORMATION
Contraindications: Qbrexza is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Qbrexza (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).
WARNINGS AND PRECAUTIONS
Worsening of Urinary Retention: Qbrexza should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hypertrophy or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop. Patients with a history of urinary retention were not included in the clinical studies.
Control of Body Temperature: In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as Qbrexza. Advise patients using Qbrexza to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
Operating Machinery or an Automobile: Transient blurred vision may occur with use of Qbrexza. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.
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%), were also common.
Anticholinergics: Coadministration of Qbrexza with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of Qbrexza with other anticholinergic-containing drugs.
INSTRUCTIONS FOR ADMINISTERING QBREXZA
Instruct patients to use one cloth to apply Qbrexza to both axillae by wiping the cloth across one underarm, ONE TIME. Using the same cloth, apply the medication to the other underarm, ONE TIME. Inform patients that Qbrexza can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data on Qbrexza use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
Lactation: There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Qbrexza and any potential adverse effects on the breastfed infant from Qbrexza or from the underlying maternal condition.
Renal Impairment: The elimination of glycopyrronium is severely impaired in patients with renal failure.
Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. The company’s approved treatment, Qbrexza™ (glycopyrronium) cloth, is an anticholinergic indicated for the topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older. Primary axillary hyperhidrosis is excessive underarm sweating with no known cause and beyond what is needed for normal body temperature regulation.
In addition to filings with the Securities and Exchange Commission (
The information in this news release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. This news release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to Dermira’s hope that Qbrexza will not only provide the clinical benefit to sufferers of primary axillary hyperhidrosis, but help to reduce the overall daily burden this condition has had on their lives; Qbrexza’s potential to be a meaningful treatment option that will not only reduce a person’s sweat, but will reduce the overall impact of primary axillary hyperhidrosis on their lives; the commercial launch of Qbrexza; and the date by which Qbrexza will be commercially available nationwide. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; Dermira’s ability to attract and retain key employees; Dermira’s ability to obtain necessary additional capital; market acceptance of Dermira’s potential products; Dermira’s ability to develop and maintain collaborations and license products and intellectual property; the impact of competitive products and therapies, including generics and biosimilars; Dermira’s ability to manage the growth and complexity of its organization; Dermira’s ability to maintain, protect and enhance its intellectual property; the design, implementation and outcomes of Dermira’s clinical trials; the outcomes of Dermira’s future meetings with regulatory agencies; and Dermira’s ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Reports on Form 10-Q and other filings