formula of C26H37NO7S and a molecular weight of 507.6. The structural formula is representedbelow:

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Glycopyrronium is a competitive inhibitor of acetylcholine receptors that are located on certainperipheral tissues, including sweat glands. In hyperhidrosis, glycopyrronium inhibits the action of

acetylcholine on sweat glands, reducing sweating.

12.2 Pharmacodynamics

The pharmacodynamics of Qbrexza are not known.

12.3 Pharmacokinetics

Absorption

The pharmacokinetics of glycopyrronium were eva luated in adult and pediatric patients withprimary axillary hyperhidrosis following Qbrexza once daily applied to the axillae for 5 days. The

mean ± SD exposures of glycopyrronium are presented in Tables 3 and 4. There was noevidence of accumulation. 

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Table 3: Mean ± SD Plasma Exposures of Glycopyrronium in Adults Following

Qbrexza Once Daily for 5 days

Parameter Adult Patients

Cmax (ng/mL) 0.08 ± 0.04

AUC0-6h (h*ng/mL) 0.2 ± 0.14

AUC0-24h (h*ng/mL) 0.88 ± 0.57

Median Tmax (Range) (h) 1 (0, 10)

Abbreviations: Maximum concentration (Cmax), Area under the time concentration curve(AUC) between 0 and 6 hours following administration of Qbrexza (AUC0-6h), AUC between

0 and 24 hours following administration of Qbrexza (AUC0-24h)DistributionAfter IV administration, glycopyrronium has a mean volume of distribution in children aged 1 to

14 years of approximately 1.3 to 1.8 L/kg, with a range from 0.7 to 3.9 L/kg. In adults aged60-75 years, the volume of distribution was lower (0.42 L/kg ± 0.22).

Elimination

Metabolism

A small proportion of glycopyrronium is metabolized following IV administration. The metabolicpathway for glycopyrronium is not characterized.

Excretion

Following administration of a single radiolabeled IV glycopyrronium dose to adult subjects whounderwent surgery for cholelithiasis, approximately 85% of total radioactivity was excreted in

urine and < 5% was present in bile drainage. Greater than 80% of the radioactivity in both urineand bile was unchanged drug.

Specific Populations

The pharmacokinetics of glycopyrronium were not eva luated in pregnant women or patients withhepatic impairment.

Pediatric Subjects

The mean ± SD exposures of glycopyrronium in pediatric subjects following Qbrexza once daily

for 5 days are presented in Table 4. There was no evidence of accumulation.

Table 4: Mean ± SD Plasma Exposures of Glycopyrronium in Pediatric Subjects

Aged 10 to 17 years Following Qbrexza Once Daily for 5 days

Parameter Pediatric Subjects

Cmax (ng/mL) 0.07 ± 0.06

AUC0-6h (h*ng/mL) 0.18 ± 0.13

AUC0-24h (h*ng/mL) Not calculated

Median Tmax (Range) (h) 1.5 (0, 6)

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Patients with Renal Impairment

Following a 4 mcg/kg IV dose of a glycopyrronium formulation for IV use, mean glycopyrroniumAUC (10.6 mcg·h/L), CL (0.43 L/h/kg) and 3-hour urinary excretion (0.7%) were significantly