Sofpironium

Sofpironium bromide is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. Sofpironium bromide indirectly reduces the rate of sweating by preventing the stimulation of these receptors.

• SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. SOFDRA is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older ( 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 anticholinergic effect of SOFDRA (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren's syndrome) ( 4 ).contraindicated

Do not shave armpits at least 8 hours before applying SOFDRA. Do not shower at least 30 minutes before applying SOFDRA. Apply SOFDRA to clean, dry skin once a day at bedtime. Apply a single pump actuation to the top of the supplied applicator. Spread the entire amount to cover 1 underarm. Apply a separate, single pump actuation to the top of the supplied applicator. Apply the entire amount to the second underarm. Allow to dry completely (5 minutes) before putting on clothing. Wash hands immediately with soap. For topical use only. Avoid fire, flame, and smoking during and immediately following application. Do not shower or wash underarms for at least 8 hours after application. Do not touch underarms after applying SOFDRA. Do not use more than once daily. Avoid transfer of SOFDRA to the periocular area [see Warnings and Precautions (5.3) ] . Do not apply SOFDRA to broken skin. Avoid using SOFDRA with occlusive dressings. Apply 1 pump of SOFDRA per underarm once a day at bedtime. For topical use only ( 2 ).

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 with use of SOFDRA. If blurred vision occurs, discontinue use and avoid operating a motor vehicle or other machinery until symptoms resolve ( 5.3 ). 5.1 Urinary Retention Use SOFDRA with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hypertrophy or bladder-neck obstruction. Discontinue use immediately and consult a healthcare provider should any of these signs or symptoms develop. 5.2 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, including SOFDRA. Watch for generalized lack of sweating when in hot or very warm environmental temperatures and avoid using SOFDRA if not sweating under these conditions. 5.3 Operating Machinery or an Automobile Transient blurred vision may occur with use of SOFDRA.

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 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two double-blind, vehicle controlled clinical trials (CARDIGAN 1 and CARDIGAN 2) of 700 subjects 10 to 76 years of age (353 subjects treated with SOFDRA and 347 subjects treated with vehicle), 44% of subjects were male, 79% were White, 21% were Black, and 1% were Asian. A total of 618 subjects completed at least 6 weeks of treatment, including 307 subjects treated with SOFDRA and 311 subjects treated with vehicle. Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with SOFDRA.

8.1 Pregnancy Risk Summary There are no available data with SOFDRA use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of sofpironium bromide to pregnant rats and rabbits during the period of organogenesis resulted in no significant adverse effects at doses 31 and 10 times, respectively, the maximum recommended human dose (MRHD) ( see Data ). The background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryofetal development study in rats, sofpironium bromide was not associated with embryofetal lethality or fetal malformations at subcutaneous dose levels of 1, 3, and 10 mg/kg/day administered during the period of organogenesis. The maternal and fetal survival, growth and development no observed adverse effect level (NOAEL) was 10 mg/kg/day (31 times the MRHD based on AUC comparisons).

Metabolism

Absorption The 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.

In case of an overdose, remove the topically applied product with soap and water, and treat the symptoms and signs attributed to the overdose symptomatically. Consider contacting the Poison Center at 1-800-222-1222 for the latest recommendations.

• Jun 18, 2024NDANDA217347Botanix Sb

1. 1Vision Blurred6534%
2. 2Dry Mouth4523%
3. 3Application Site Pain2815%
4. 4Mydriasis2614%
5. 5Application Site Irritation2111%
6. 6Application Site Rash189.4%
7. 7Urinary Retention178.9%
8. 8Drug Ineffective157.8%
9. 9Dysuria115.7%
10. 10Rash115.7%
11. 11Application Site Erythema105.2%
12. 12Application Site Pruritus94.7%
13. 13Off Label Use84.2%
14. 14Visual Impairment84.2%
15. 15Dry Eye73.6%

The 6 most recently updated of 6 ClinicalTrials.gov registrations naming Sofpironium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
  Completed · Phase 3 · Interventional · 350 enrolled · Botanix Pharmaceuticals
  NCT03836287updated 2024-06-06
• Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)
  Completed · Phase 3 · Interventional · 351 enrolled · Botanix Pharmaceuticals
  NCT03948646updated 2024-05-21
• A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis
  Completed · Phase 2 · Interventional · 50 enrolled · Botanix Pharmaceuticals
  NCT02682238updated 2023-05-19
• A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis
  Completed · Phase 3 · Interventional · 300 enrolled · Botanix Pharmaceuticals
  NCT03627468updated 2023-05-19
• A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
  Completed · Phase 2 · Interventional · 227 enrolled · Botanix Pharmaceuticals
  NCT03024255updated 2023-05-16
• A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis
  Completed · Phase 2 · Interventional · 21 enrolled · Botanix Pharmaceuticals
  NCT03785587updated 2023-03-14

Frequently asked questions

How does Sofpironium work?

Sofpironium bromide is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. Sofpironium bromide indirectly reduces the rate of sweating by preventing the stimulation of these receptors.

What is Sofpironium used for?

According to FDA labeling, Sofpironium carries indications including: SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. SOFDRA is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sofpironium?

Sofpironium is classified as Cholinergic Muscarinic Antagonists, Antiperspirant Activity.

What are the brand names for Sofpironium?

Sofpironium is marketed under brand names including Sofdra.

What are the contraindications for Sofpironium?

Sofpironium labeling lists contraindications including: 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 anticholinergic effect of SOFDRA (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren's syndrome) ( 4 ).. Always consult the full prescribing information and a clinician.