– Study will assess the impact of QBREXZA treatment on sweat severity in patients with primary palmar hyperhidrosis
– Results will inform potential development plans for QBREXZA in primary palmar hyperhidrosis
– Findings from the study are expected in the second half of 2019
MENLO PARK, CA, USA I February 22, 2019 I Dermira, Inc. (NASDAQ: DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of people living with chronic skin conditions, announced today the initiation of a proof-of-concept study that will evaluate the efficacy and safety of QBREXZA™ (glycopyrronium) cloth in people living with primary palmar hyperhidrosis (excessive sweating of the hands).
QBREXZA is a once-daily, prescription anticholinergic that was approved by the U.S. Food and Drug Administration (FDA) to treat adult and pediatric patients 9 years of age and older living with primary axillary hyperhidrosis, a medical condition commonly referred to as excessive underarm sweating.
“People suffering from palmar hyperhidrosis frequently cite it as debilitating, difficult to effectively manage and a major influence on their life choices,” said Lisa J. Pieretti, Executive Director for the International Hyperhidrosis Society and a patient advocate for more than 15 years. “New treatment alternatives are needed to help manage this condition, which can have a significant negative impact on everything from a child’s time on a playground to an individual’s first job interview.”
Hyperhidrosis is a condition that often affects multiple parts of a person’s body. In the Phase 3 clinical trials that led to the approval of QBREXZA for axillary hyperhidrosis, 34% of the people participating also reported suffering from palmar hyperhidrosis. QBREXZA is not currently FDA-approved to treat primary palmar hyperhidrosis, a condition that affects approximately six million people in the United States.1
Following the approval of QBREXZA in 2018, Dermira initiated preclinical research studies designed to understand how glycopyrronium tosylate could benefit other areas of the body beyond the axillae (underarms). Specifically, these studies tested whether glycopyrronium tosylate penetration into human skin is impacted by occlusion (covering the skin), washing the skin and skin thickness. The findings from these studies helped to inform the proof-of-concept study design.
“We have long recognized that, similar to axillary hyperhidrosis, palmar hyperhidrosis is highly prevalent and can adversely affect the emotional and social well-being of people living with this condition,” said Luis Peña, chief development officer of Dermira. “Given our commitment to the hyperhidrosis patient community, the goal of the proof-of-concept study is to determine if the current formulation of QBREXZA is effective in reducing sweat production on a person’s hands, which would allow us to determine if there is a viable development and regulatory path for the treatment of primary palmar hyperhidrosis.”
The randomized, vehicle-controlled, parallel group proof-of-concept study is designed to determine an appropriate dosing regimen for QBREXZA to treat primary palmar hyperhidrosis. The study will enroll approximately 60 patients ages 9 years and older at eight sites in the United States. Findings from the study are expected in the second half of 2019 and will inform next steps for a potential primary palmar hyperhidrosis development program.
About Hyperhidrosis
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), while 40 percent suffer from sweating on their hands. 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
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 9 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.
About Dermira
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, develop and commercialize leading-edge medical dermatology products. The company’s approved treatment, QBREXZA™ (glycopyrronium) cloth, is indicated for pediatric and adult patients (ages 9 and older) with primary axillary hyperhidrosis (excessive underarm sweating). Dermira is also evaluating lebrikizumab in a Phase 2b clinical trial for the treatment of moderate-to-severe atopic dermatitis (a severe form of eczema) and has early-stage research programs in other areas of dermatology. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com. Follow Dermira on Twitter, LinkedIn and Instagram.
- Doolittle et. al., Hyperhidrosis: An Update on Prevalence and Severity in the United States. Arch Dermatol Res. 308:743-749, 2016.
- Kamudoni, et al., The impact of hyperhidrosis on patients’ daily life and quality of life: a qualitative investigation. Health and Quality of Life Outcomes, 15(1). 2017.
SOURCE: Dermira
Post Views: 31
– Study will assess the impact of QBREXZA treatment on sweat severity in patients with primary palmar hyperhidrosis
– Results will inform potential development plans for QBREXZA in primary palmar hyperhidrosis
– Findings from the study are expected in the second half of 2019
MENLO PARK, CA, USA I February 22, 2019 I Dermira, Inc. (NASDAQ: DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of people living with chronic skin conditions, announced today the initiation of a proof-of-concept study that will evaluate the efficacy and safety of QBREXZA™ (glycopyrronium) cloth in people living with primary palmar hyperhidrosis (excessive sweating of the hands).
QBREXZA is a once-daily, prescription anticholinergic that was approved by the U.S. Food and Drug Administration (FDA) to treat adult and pediatric patients 9 years of age and older living with primary axillary hyperhidrosis, a medical condition commonly referred to as excessive underarm sweating.
“People suffering from palmar hyperhidrosis frequently cite it as debilitating, difficult to effectively manage and a major influence on their life choices,” said Lisa J. Pieretti, Executive Director for the International Hyperhidrosis Society and a patient advocate for more than 15 years. “New treatment alternatives are needed to help manage this condition, which can have a significant negative impact on everything from a child’s time on a playground to an individual’s first job interview.”
Hyperhidrosis is a condition that often affects multiple parts of a person’s body. In the Phase 3 clinical trials that led to the approval of QBREXZA for axillary hyperhidrosis, 34% of the people participating also reported suffering from palmar hyperhidrosis. QBREXZA is not currently FDA-approved to treat primary palmar hyperhidrosis, a condition that affects approximately six million people in the United States.1
Following the approval of QBREXZA in 2018, Dermira initiated preclinical research studies designed to understand how glycopyrronium tosylate could benefit other areas of the body beyond the axillae (underarms). Specifically, these studies tested whether glycopyrronium tosylate penetration into human skin is impacted by occlusion (covering the skin), washing the skin and skin thickness. The findings from these studies helped to inform the proof-of-concept study design.
“We have long recognized that, similar to axillary hyperhidrosis, palmar hyperhidrosis is highly prevalent and can adversely affect the emotional and social well-being of people living with this condition,” said Luis Peña, chief development officer of Dermira. “Given our commitment to the hyperhidrosis patient community, the goal of the proof-of-concept study is to determine if the current formulation of QBREXZA is effective in reducing sweat production on a person’s hands, which would allow us to determine if there is a viable development and regulatory path for the treatment of primary palmar hyperhidrosis.”
The randomized, vehicle-controlled, parallel group proof-of-concept study is designed to determine an appropriate dosing regimen for QBREXZA to treat primary palmar hyperhidrosis. The study will enroll approximately 60 patients ages 9 years and older at eight sites in the United States. Findings from the study are expected in the second half of 2019 and will inform next steps for a potential primary palmar hyperhidrosis development program.
About Hyperhidrosis
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), while 40 percent suffer from sweating on their hands. 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
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 9 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.
About Dermira
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, develop and commercialize leading-edge medical dermatology products. The company’s approved treatment, QBREXZA™ (glycopyrronium) cloth, is indicated for pediatric and adult patients (ages 9 and older) with primary axillary hyperhidrosis (excessive underarm sweating). Dermira is also evaluating lebrikizumab in a Phase 2b clinical trial for the treatment of moderate-to-severe atopic dermatitis (a severe form of eczema) and has early-stage research programs in other areas of dermatology. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com. Follow Dermira on Twitter, LinkedIn and Instagram.
- Doolittle et. al., Hyperhidrosis: An Update on Prevalence and Severity in the United States. Arch Dermatol Res. 308:743-749, 2016.
- Kamudoni, et al., The impact of hyperhidrosis on patients’ daily life and quality of life: a qualitative investigation. Health and Quality of Life Outcomes, 15(1). 2017.
SOURCE: Dermira
Post Views: 31
