SOFDRA (sofpironium bromide)

AbsorptionThe pharmacokinetics of sofpironium were evaluated in adult patients with primary axillary hyperhidrosis following SOFDRA applied once daily to the underarms for 21 days. The mean ± standard deviation (SD) exposures of sofpironium in adults are presented in Table 3. There was no evidence of accumulation.

Table 3Mean (SD) Plasma Exposure of Sofpironium in Adults with Primary Axillary Hyperhidrosis Following SOFDRA Application on Day 1 PK Parameter Adult Patients C max (ng/mL) 2.71 (6...

Two randomized, vehicle-controlled multicenter trials, CARDIGAN 1 (NCT03836287) and CARDIGAN 2 (NCT03948646), enrolled a total of 701 subjects 10 years of age or older with primary axillary hyperhidrosis. All subjects were to have symptoms of axillary hyperhidrosis for at least 6 months' duration, produce at least 50 mg of sweat in each axilla (underarm) with a combined total of at least 150 mg over a 5-minute period, and have a Hyperhidrosis Disease Severity Measure-Axillary, 7-item scale score (HDSM-Ax-7) ≥3. In the trials, 56% of subjects were female, 78% were White, and 20% were Black or A...

The following clinically significant adverse reactions are described elsewhere in the labeling: Urinary Retention [see Warnings and Precautions (5.1) ]. Most common adverse reactions (incidence ≥2%) are dry mouth, vision blurred, application site pain, application site erythema, mydriasis, application site dermatitis, application site pruritus, urinary retention, and application site irritation ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Botanix SB Inc. at 1-866-763-6337 or FDA at 1-...

SOFDRA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of sofpironium bromide (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren's syndrome). Medical conditions that can be exacerbated by the anticholi...

Urinary Retention: Use with caution in patients with a history or presence of documented urinary retention. Discontinue use immediately and consult a healthcare provider should any signs or symptoms of urinary retention develop ( 5.1 ). Control of Body Temperature: Watch for generalized lack of sweating when in hot or very warm environmental temperatures and avoid using SOFDRA if not sweating under these conditions ( 5.2 ). Operating Machinery or an Automobile: Transient blurred vision may occur...

7 DRUG INTERACTIONS Anticholinergics: Coadministration of SOFDRA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of SOFDRA with other anticholinergic-containing drugs ( 7.1 ). Strong Inhibitors of CYP2D6: Avoid co-administration of SOFDRA with drugs that are strong inhibitors of CYP2D6 ( 7.2 ). 7....