The first and only prescription cloth towelette approved to treat primary axillary hyperhidrosis in people nine years of age and older is Journey Medical’s seventh marketed dermatology product
Journey Medical Corporation (“Journey Medical”), a partner company of Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), today announced that it has entered into a definitive agreement to acquire QBREXZA (glycopyrronium) in the U.S. from Dermira, Inc., a wholly-owned subsidiary of Eli Lilly and Company.
The transaction is expected to close early in the second quarter of this year. QBREXZA generated $24 million in net sales in the U.S. in 2020.
QBREXZA is the only topical product to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of primary axillary hyperhidrosis in adult and pediatric populations (ages nine years and older) and is self-administered by patients. Additionally, QBREXZA is noted as a first-line treatment therapy for primary axillary hyperhidrosis by the International Hyperhidrosis Society (IHHS).
Claude Maraoui, President and Chief Executive Officer of Journey Medical, stated, “We are thrilled to expand our footprint in dermatology with the addition of QBREXZA to our growing portfolio of prescription dermatology brands. Acquiring QBREXZA will allow us to provide an accessible and convenient product to the millions of Americans who seek relief from excessive underarm sweating, many of whom remain undiagnosed and untreated.”
In two key pivotal trials within adult and pediatric patients with primary axillary hyperhidrosis, the use of QBREXZA resulted in clinically meaningful improvements in gravimetrically measured sweat production and disease severity, as measured by the Axillary Sweating Daily Diary, which was a validated, disease-specific patient-reported outcome developed in consultation with the FDA. The safety and efficacy of QBREXZA have been established in clinical trials with treatment for up to 48 weeks.
Hyperhidrosis is a condition of sweating beyond what is physiologically required for normal thermal regulation and affects an estimated 4.8% of the U.S. population, or approximately 15 million people.1 Of these, 65 percent, or nearly 10 million people, suffer from sweating localized to the underarms (axillary disease). Studies have demonstrated that excessive sweating often impedes normal daily activities and can also result in occupational, emotional, psychological, social, and physical impairment.1,2
Lindsay A. Rosenwald, M.D., Chairman, President, and Chief Executive Officer of Fortress added, “The acquisition of QBREXZA marks continued progress for our partner company, Journey Medical, and demonstrates the success of Fortress’ unique business model, which is designed to acquire and rapidly advance potentially transformative products and product candidates to patients.”
For additional information about QBREXZA, please visit https://www.QBREXZA.com/.
About QBREXZA® (glycopyrronium) cloth
QBREXZA (pronounced kew brex’ zah) is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients, nine years of age and older. QBREXZA is applied directly to the skin and is designed to block sweat production by inhibiting sweat gland activation. For more information visit www.QBREXZA.com.
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 the 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.