Enter drug's generic or brand name below. Results will appear here. Note: all drug related information obtained on this page is provided by RX List.
Using the RX LIST database:
(1) Enter the drug name in the search box below and hit ENTER
(2) The rx list web site will open here with the drug search completed. Next, scroll down the page to locate the link to the drug you are searching for and then click on the link.
SOFDRA (sofpironium) topical gel is an anticholinergic drug. Sofpironium bromide drug substance is a white to off white powder with the chemical name 3'(R)-[2(R) cyclopentylphenylhydroxy-acetoxy]-1'-methyl-1'-ethoxycarbonylmethyl-pyrrolidinium bromide, very soluble in chloroform and freely soluble in water, ethanol, acetonitrile, and methanol, molecular formula of C22H32BrNO5, molecular weight of 470.4 g/mol, and the following structural formula:
 |
SOFDRA is a clear to translucent, colorless to pale yellow viscous gel containing 12.45% (w/w) sofpironium (equivalent to 15% sofpironium bromide) in an airless bottle sealed with a multi-dose metered pump. Each pump delivers 72 mg of sofpironium (equivalent to 87 mg of sofpironium bromide) in 0.67 mL of gel. The inactive ingredients are citric acid, 77.2% v/v dehydrated alcohol, hexylene glycol, hydroxypropyl cellulose, and isopropyl myristate.
SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.
Topical gel: 12.45% (w/w) of sofpironium in a 50 mL bottle with a metered dose pump and applicator. One full pump delivers 72 mg sofpironium in 0.67 mL of gel.
SOFDRA topical gel is supplied in a bottle with a multi-dose metered pump, applicator, and cap. Each bottle contains 50 mL of gel with a multi-dose pump capable of dispensing 60 pump actuations. Each pump actuation dispenses 0.67 mL of gel.
NDC 83723-010-50
Store upright at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
SOFDRA is flammable; keep away from heat or flame.
Manufactured for: Botanix SB Inc., Wayne, PA 19087. Revised: Jun 2024
The following clinically significant adverse reactions are described elsewhere in the labeling:
Urinary Retention [see WARNINGS AND PRECAUTIONS]
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.
Table 1: Adverse Reactions Occurring in ≥2% of Subjects with Primary Axillary Hyperhidrosis Treated with SOFDRA in Trials CARDIGAN 1 and 2
| Adverse Reactions | SOFDRA (N = 353) n (%) |
Vehicle (N = 347) n (%) |
| Dry mouth | 51 (14%) | 2 (0.6%) |
| Vision blurred | 30 (9%) | 1 (0.3%) |
| Mydriasis | 23 (7%) | 0 |
| Urinary retention | 8 (2%) | 0 |
| Note: COVID-19 was observed in 8 (2%) SOFDRA and 2 (0.6%) vehicle subjects. | ||
Table 2 shows the local skin reactions reported ≥2%, which occurred more commonly in the SOFDRA group.
Table 2: Local Skin Reactions Reported in ≥2% of Subjects with Primary Axillary Hyperhidrosis Treated with SOFDRA in Trials CARDIGAN 1 and 2
| Local Skin Adverse Reactions | SOFDRA (N = 353) n (%) |
Vehicle (N = 347) n (%) |
| Pain | 29 (8%) | 6 (2%) |
| Erythema | 23 (7%) | 1 (0.3%) |
| Dermatitis | 21 (6%) | 1 (0.3%) |
| Pruritus | 16 (5%) | 2 (0.6%) |
| Irritation | 8 (2%) | 1 (0.3%) |
| Exfoliation | 7 (2%) | 1 (0.3%) |
In an open-label, long-term safety trial (ARGYLE), 197 subjects were treated for 48 weeks with SOFDRA. Adverse reactions occurring at a frequency ≥2% were vision blurred (19%), dry mouth (17%), application site pruritus (15%), application site pain (15%), application site dermatitis (11%), application site erythema (8%), application site irritation (6%), mydriasis (5%), application site rash (4%), upper respiratory tract infection (4%), dry eye (4%), urinary retention (4%), application site exfoliation (3%), application site folliculitis (3%), hypertension (3%), application site dryness (2%), viral upper respiratory tract infection (2%), influenza (2%), and headache (2%).
Coadministration of SOFDRA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. Avoid coadministration of SOFDRA with other anticholinergic-containing drugs.
Avoid co-administration of SOFDRA with drugs that are strong inhibitors of CYP2D6.
Included as part of the "PRECAUTIONS" Section
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.
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.
Transient blurred vision may occur with use of SOFDRA. If blurred vision occurs, discontinue use and avoid engaging in activities that require clear vision, such as operating a motor vehicle or other machinery or performing hazardous work, until the symptoms have resolved.
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).
Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder). Instruct patients to discontinue use and consult a healthcare provider immediately should any of these signs or symptoms develop [see WARNINGS AND PRECAUTIONS].
Advise patients that in the presence of high ambient temperature, heat illness due to decreased sweating can occur with the use of SOFDRA. Advise patients to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid using SOFDRA if not sweating under these conditions [see WARNINGS AND PRECAUTIONS].
Advise patients that transient blurred vision may occur with SOFDRA. If this occurs, instruct patients to contact their healthcare provider, discontinue use of SOFDRA, and avoid operating a motor vehicle or other machinery or performing hazardous work until symptoms resolve [see WARNINGS AND PRECAUTIONS].
Advise patients as follows [see DOSAGE AND ADMINISTRATION]:
The carcinogenic potential of sofpironium bromide was assessed in a 2-year dermal mouse carcinogenicity study and a 2-year subcutaneous rat carcinogenicity study. There were no drug-related neoplasms associated with daily topical administration of sofpironium bromide topical gel to mice at doses of up to 20% sofpironium bromide (2 times and 11 times the MRHD based on AUC comparisons for males and females, respectively). No drug-related neoplasms were identified in rats administered daily subcutaneous doses up to 1.5 mg/kg/day (males) and 5.0 mg/kg/day (females) (4 times and 12 times the MRHD based on AUC comparisons for males and females, respectively).
Sofpironium bromide was not mutagenic in a bacterial mutagenicity assay (Ames assay) or clastogenic in an in vitro mammalian chromosomal aberration assay (human peripheral blood lymphocytes) or in an in vivo micronucleus assay in rats.
There were no sofpironium bromide-related effects on male or female fertility and early embryonic developmental endpoints in rats at subcutaneous doses up to 10 mg/kg/day (70 and 20 times the MRHD based on AUC comparisons for males and females, respectively).
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.
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).
In an embryofetal development study in rabbits, sofpironium bromide was administered by subcutaneous injection to pregnant rabbits at doses of 0.4, 2 and 10 mg/kg/day during the period of organogenesis. Maternal toxicity as evidenced by decreased maternal body weight gain and feed consumption was observed in all sofpironium bromide treated groups. The decrease in maternal body weight was considered severe at 10 mg/kg/day and was associated with embryofetal lethality. The maternal toxicity NOAEL could not be established in the study. The NOAEL for embryo-fetal development toxicity was 2 mg/kg/day (10 times the MRHD based on AUC comparison). Fetal malformation was not observed with sofpironium bromide treatment at doses up to 10 mg/kg/day (57 times the MRHD based on AUC comparison) in rabbits.
In a pre-and postnatal development study, sofpironium bromide was administered by subcutaneous injection to pregnant rats at doses of 1, 3 and 6 mg/kg/day beginning on gestation day 6 through lactation day 20. Maternal toxicity associated with a 17% decrease in body weight gain noted at 6 mg/kg/day (approximately 19 times the MRHD based on AUC comparisons) when compared to the control group. No sofpironium bromide-related effects on prenatal and postnatal development, neurobehavioral or reproductive performance of offspring were noted at doses up to 6 mg/kg/day (approximately 19 times the MRHD based on AUC comparison).
There are no data on the presence of SOFDRA or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOFDRA and any potential adverse effects on the breastfed infant from sofpironium bromide or from the underlying maternal condition.
Sofpironium bromide was detected in milk following single subcutaneous administration to lactating rats (see Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk.
Animal Data
Milk excretion studies in vivo showed sofpironium or its metabolites were transferred into the milk after a single subcutaneous administration of 0.5 mg/kg to lactating rats on postnatal day 10.
The safety, effectiveness, and pharmacokinetics of SOFDRA for the treatment of primary axillary hyperhidrosis have been established in pediatric patients 9 years of age and older [See Clinical Pharmacology]. Use of SOFDRA in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 6-week trials and two multicenter, open-label, 24-week and 48-week trials, which included 72 pediatric subjects 9 years of age and older [see ADVERSE REACTIONS and Clinical Studies].
The safety and effectiveness of SOFDRA have not been established in pediatric patients younger than 9 years of age.
Clinical trials of SOFDRA did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
The safety and effectiveness of SOFDRA in populations with renal impairment have not been established.
The safety and effectiveness of SOFDRA in populations with hepatic impairment have not been established.
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.
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).
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.
Pharmacodynamics of SOFDRA are unknown.
At an exposure 3 times the exposure associated with the maximum approved recommended dose, SOFDRA does not prolong the QTc interval to any clinically relevant extent.
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. There was no evidence of accumulation.
Table 3: Mean (SD) Plasma Exposure of Sofpironium in Adults with Primary Axillary Hyperhidrosis Following SOFDRA Application on Day 1
| PK Parameter | Adult Patients |
| Cmax (ng/mL) | 2.71 (6.94) |
| AUC0-t (ng·hr/mL) | 45.1 (85.1) |
| tmax (hr) | 5.34 (5.45) |
Plasma protein binding of sofpironium is around 34.8-37.8%. The major sofpironium metabolite (BBI-4010) had plasma protein binding around 2.3-3.7%.
Metabolism
Sofpironium is metabolized by nonenzymatic hydrolysis, CYP2D6 and CYP3A4 mediated-oxidative metabolism, and glycine conjugation. In plasma, sofpironium was the major component (38%) followed by the BBI-4010 (20%) metabolite.
Excretion
Urinary excretion of sofpironium and BBI-4010 were less than 0.5% of the applied dose.
The pharmacokinetics of sofpironium were not evaluated in pregnant patients or patients with hepatic or renal impairment.
The mean ± SD exposures of sofpironium after a single dose in pediatric subjects 9 years to 16 years of age are presented in Table 4. After 24 weeks of dosing, trough concentrations of sofpironium were low and there was no evidence of accumulation. The exposure to major metabolite (BBI-4010) in pediatric subjects was similar to sofpironium exposure in adults.
Table 4: Mean (SD) Plasma Exposure of Sofpironium in Pediatric Subjects Following Single Dose Administration of SOFDRA on Day 1
| PK Parameter | Pediatric Patients |
| Cmax (ng/mL) | 1.30 (3.16) |
| AUC0-t (ng·hr/mL) | 14.6 (35.0) |
| tmax (hr) | 4.0 (0.9, 23.1) |
| tmax reported as median and range. | |
No clinically significant differences in sofpironium pharmacokinetics were observed when used concomitantly with inhibitors of, CYP3A4, OCT2, MATE1, or MATE2-K.
In presence of 20 mg oral dose of paroxetine HCl (strong CYP2D6 inhibitor) Cmax and AUC0-t of sofpironium increased by approximately twofold compared to when SOFDRA was administered alone.
Sofpironium is an inhibitor of CYP2D6, CYP3A4, OCT1, OCT2, and MATE1 in vitro. Sofpironium is not an inducer of CYP1A2, CYP2B6, or CYP3A4.
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-Ax7) ≥3.
In the trials, 56% of subjects were female, 78% were White, and 20% were Black or African American; for ethnicity, 31% identified as Hispanic or Latino. Fewer than 1% of subjects were less than 12 years of age, 7% were 12 to 17 years of age, 91% were 18 to 64 years of age, and 1% were 65 years of age or older.
Subjects 12 years of age and older were asked to rate their underarm sweating severity and frequency since waking on the previous day (“since you woke up yesterday”) on the 11-item HDSM-Ax Adult version instrument. The HDSM-Ax-7 scale score was calculated by taking an average of 7 items, where the scale score ranges from 0 to 4 with a higher score representing greater underarm sweating severity. The mean HDSMAx-7 scale score at Baseline was 3.5 in CARDIGAN 1, and 3.6 in CARDIGAN 2. The median gravimetric sweat production (GSP) over 5 minutes at Baseline was 214.1 mg in the SOFDRA arm and 228.6 mg in the vehicle arm in CARDIGAN 1, and 207.7 mg in the SOFDRA arm and 231.1 mg in the vehicle arm in CARDIGAN 2.
Subjects were randomized to receive either SOFDRA or vehicle applied once daily at bedtime to each axilla. The co-primary endpoints were the proportion of subjects having at least a 2-point improvement in the HDSM-Ax-7 scale score from Baseline to Day 43, and the change in GSP from Baseline to Day 43.
The results of CARDIGAN 1 and CARDIGAN 2 are presented in Table 5.
Table 5: Primary Efficacy Endpoints at Day 43 in Subjects with Primary Axillary Hyperhidrosis in Trials CARDIGAN 1 and 2
| CARDIGAN 1 | CARDIGAN 2 | |||
| SOFDRA | Vehicle | SOFDRA | Vehicle | |
| ≥2 point Improvement in HDSM-Ax-7a scale score from Baseline to Day 43 in subjects 12 years of age and older | N = 172 49% | N= 177 29% | N = 178 64% | N = 169 48% |
| Treatment Difference 95% Confidence Interval | 18% (8%, 29%) |
17% (6%, 27%) |
||
| Baseline Median GSPb in subjects 10 years of age and older (mg/5 minutes) | N = 173 214 | N = 177 229 | N = 180 208 | N = 171 231 |
| Change from Baseline to Day 43 Median (mg/5 minutes)25th percentile, 75th percentile | -128 -201, -52 |
-100 -228, -29 |
-143 -260, -75 |
-134 -230, -60 |
| a Hyperhidrosis Disease Severity Measure-Axillary, 7-item score b Gravimetric Sweat Production |
||||
SOFDRA™
(sof-drah)
(sofpironium) topical gel, 12.45%
Important information: SOFDRA is for use on the skin in the underarm area only. Do not apply SOFDRA to other parts of your body.
What is SOFDRA?
SOFDRA is a prescription anticholinergic medicine used on the skin (topical) to treat excessive underarm sweating (primary axillary hyperhidrosis) in adults and children 9 years of age and older. It is not known if SOFDRA is safe and effective in children under 9 years of age.
Who should not use SOFDRA?
Do not use SOFDRA if you have certain medical conditions that can be made worse by taking an anticholinergic medicine such as:
Talk to your healthcare provider if you are not sure if you have a medical condition that can be made worse by taking an anticholinergic medicine.
Before using SOFDRA, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
SOFDRA may affect the way other medicines work causing side effects. Especially tell your healthcare provider if you take anticholinergic medicines.
Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use SOFDRA?
What should I avoid while using SOFDRA?
What are possible side effects of SOFDRA?
SOFDRA can cause serious side effects, including:
The most common side effects of SOFDRA include:
These are not all of the possible side effects of SOFDRA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SOFDRA?
Keep SOFDRA and all medicines out of the reach of children.
General information about the safe and effective use of SOFDRA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOFDRA for a condition for which it was not prescribed. Do not give SOFDRA to other people, even if they have the same condition you have. You can ask your pharmacist or healthcare provider for information about SOFDRA that is written for healthcare professionals.
What are the ingredients in SOFDRA?
Active ingredient: sofpironium
Inactive ingredients: citric acid, dehydrated alcohol, hexylene glycol, hydroxypropyl cellulose, and isopropyl myristate.
This Patient Information has been approved by the U.S. Food and Drug Administration.
