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Qbrexza (glycopyrronium) is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.

Qbrexza is an anticholinergic drug available as a 2.4% solution on a single-use cloth towelette, packaged in a pouch for topical administration. The inactive ingredients are citric acid, dehydrated alcohol, purified water, and sodium citrate. Qbrexza is available in a carton of 30 pouches.

Glycopyrronium is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. Qbrexza inhibits the action of acetylcholine on sweat glands, reducing sweating.1

Qbrexza is for topical use in the underarm area only and not for use in other body areas.

Qbrexza should be applied to clean dry skin on the underarm areas only. Qbrexza should not be used more frequently than once every 24 hours.

How to use Qbrexza:

  1. Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entire underarm once. Using the same cloth, wipe the other underarm once. A single cloth should be used to apply Qbrexza to both underarms.
  2. Wash hands immediately with soap and water after applying and discarding the Qbrexza cloth. Qbrexza may cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Avoid transfer of Qbrexza to the periocular area.

Do not apply Qbrexza to broken skin. Avoid using Qbrexza with occlusive dressings.1

Two randomized, vehicle-controlled trials, ATMOS-1 and ATMOS-2, were conducted in a total of 697 patients 9 years of age or older with primary axillary hyperhidrosis.

Subjects were randomized to receive either Qbrexza or vehicle applied once daily to each underarm.

The co-primary endpoints were:

  1. The proportion of subjects having at least a 4‑point improvement from baseline in the weekly mean ASDD item #2 score at Week 4.
  2. The mean absolute change from baseline in gravimetrically measured sweat production at Week 4.1

Contraindications

Qbrexza is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Qbrexza

Warnings and Precautions

Worsening of Urinary Retention: Qbrexza should be used with caution in patients with a history or presence of documented urinary retention.

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.

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 table below summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with Qbrexza in ATMOS-1 and ATMOS-2.

Adverse Reactions Occurring in ≥2% of Subjects1

Adverse Reactions Qbrexza
(N=459)
n (%)
Vehicle
(N=232)
n (%)
Dry mouth
111 (24.2%) 13 (5.6%)
Mydriasis
31 (6.8%) 0
Oropharyngeal pain 26 (5.7%) 3 (1.3%)
Headache 23 (5.0%) 5 (2.2%)
Urinary hesitation 16 (3.5%) 0
Vision blurred 16 (3.5%) 0
Nasal dryness 12 (2.6%) 1 (0.4%)
Dry throat 12 (2.6%) 0
Dry eye 11 (2.4%) 1 (0.4%)
Dry skin 10 (2.2%) 0
Constipation 9 (2.0%) 0

The table below shows the most frequently reported local skin reactions, which were relatively common in both the Qbrexza and vehicle groups.

Local Skin Reactions

Local Skins Reactions Qbrexza
(N=454)§
n (%)
Vehicle
(N=231)§
n (%)
Erythema 77 (17.0%) 39 (16.9%)
Burning/stinging 64 (14.1%) 39 (16.9%)
Pruritus 37 (8.1%) 14 (6.1%)

§Patients with a post-baseline local skin reaction assessment

ARIDO, 44-Week Trial

In an open-label safety trial (ARIDO), 564 subjects were treated for up to an additional 44 weeks after completing ATMOS-1 and ATMOS-2. Adverse reactions occurring at a frequency ≥2.0% were dry mouth (16.9%), vision blurred (6.7%), nasopharyngitis (5.8%), mydriasis (5.3%), urinary hesitation (4.2%), nasal dryness (3.6%), dry eye (2.9%), pharyngitis (2.2%), and application site reactions (pain [6.4%], dermatitis [3.8%], pruritus [3.8%], rash [3.8%], erythema [2.4%]).

The results of ATMOS-1 and ATMOS-2 are presented in the table below1

Primary Efficacy Outcomes in Subjects with Primary Axillary Hyperhidrosis

ATMOS-1
Qbrexza,
2.4%
N=229

Vehicle
N=115
ASDD Item #2* Response at Week 4:
Proportion of subjects with at least a 4-point improvement from baseline in the weekly mean ASDD item #2 at Week 4
53% 28%
Change from Baseline in Sweat Production at Week 4 (mg/5 minutes):
Median
25th percentile, 75th percentile
-81
-149, -40
-66
-106, -28
ATMOS-2
Qbrexza,
2.4%
N=234

Vehicle
N=119
ASDD Item #2* Response at Week 4:
Proportion of subjects with at least a 4-point improvement from baseline in the weekly mean ASDD item #2 at
66% 27%
Change from Baseline in Sweat Production at Week 4 (mg/5 minutes):
Median
25th percentile, 75th percentile
-79
-144, -45
-58
-122, -21

*ASDD item #2 is a patient-reported outcome instrument scored from 0 (no sweating) to 10 (worst possible sweating).

†The average weekly mean score on the ASDD item #2 at baseline was approximately 7.2 across both trials.

‡The median sweat production over 5 minutes at baseline was 122 mg in the Qbrexza arm and 113 mg in the vehicle arm in ATMOS-1, and 127 mg in the Qbrexza arm and 117 mg in the vehicle arm in ATMOS-2.

Qbrexza will be available October 2018.

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Reference: 1. Qbrexza™ (glycopyrronium) prescribing information, Dermira.