Qbrexza (glycopyrronium)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved June 2018

Specific Treatments:

primary axillary hyperhidrosis

Therapeutic Areas

General Information

Qbrexza (glycopyrronium) is an anticholinergic. In hyperhidrosis, glycopyrronium inhibits the action of acetylcholine on sweat glands, reducing sweating. 

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

Qbrexza is supplied as a cloth for topical administration. Qbrexza is administered by a single-use pre-moistened cloth packaged in individual pouches. 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. 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. Wash hands immediately with soap and water after applying and discarding the Qbrexza cloth.

Clinical Results

FDA Approval

The FDA approval of Qbrexza was based on two randomized, vehicle-controlled multicenter trials, Trial 1 and Trial 2, conducted in 697 subjects 9 years of age or older with primary axillary hyperhidrosis . Inclusion criteria required that prior to the start of treatment, all subjects produce at least 50 mg of sweat in each axilla over a 5-minute period and rate the severity of their sweating daily over a week with a mean score of 4 or higher on the ASDD item #2, a patient reported outcome instrument scored from 0 (no sweating) to 10 (worst possible sweating). Subjects were randomized to receive either Qbrexza or vehicle applied once daily to each axilla. The co-primary endpoints were the proportion of subjects having at least a 4-point improvement from baseline in the weekly mean ASDD item #2 score at Week 4 and the mean absolute change from baseline in gravimetrically measured sweat production at Week 4. The results for Qbrexza versus vehicle for each trial are as follows:

Trial 1 ASDD Item #2 Response at Week 4: 53% versus 28%; Change from Baseline in Sweat Production at Week 4 (mg/5 minutes): -81 versus -66. 

Trial 2 ASDD Item #2 Response at Week 4: 66% versus 27%; Change from Baseline in Sweat Production at Week 4 (mg/5 minutes): -79 versus -58.

 

Side Effects

Adverse effects associated with the use of Qbrexza may include, but are not limited to, the following:

dry mouth

mydriasis

oropharyngeal pain

headache

urinary hesitation

vision blurred

nasal dryness

dry throat

dry eye

dry skin

constipation

Local skin reactions, including erythema, burning/stinging and pruritus

Mechanism of Action

Qbrexza (glycopyrronium) is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. In hyperhidrosis, glycopyrronium inhibits the action of acetylcholine on sweat glands, reducing sweating. 

Additional Information

For additional information regarding Qbrexza or primary axillary hyperhidrosis, please visit https://www.qbrexza.com/