| Drug Name |
SOFDRA™ (sofpironium) |
| Active Ingredient |
sofpironium |
| Date of Approval |
6/18/2024
Initially scheduled for January 2024, approval was delayed to June 2024 |
| Manufacturer |
Botanix Pharmaceuticals Ltd. |
| Approval Pathways and Indications |
Approval Pathway: NDA
Indication: SOFDRA™ is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. |
| Therapeutic Class |
Anticholinergic |
| Formulation |
Topical gel: 12.45% of sofpironium |
| MoA |
SOFDRA™ 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. |
| Dosing and Administration |
Before applying SOFDRA™, patients should avoid shaving their armpits for 8 hours and refrain from showering for 30 minutes. They should apply SOFDRA™ to clean, dry skin at bedtime using one pump per underarm, ensuring complete coverage. The product should dry for 5 minutes before dressing, and hands should be washed immediately after. |
| Administered by self or by HCP |
Administered by self |
| Place in Therapy |
SOFDRA™ is the first and only new chemical entity developed for primary axillary hyperhidrosis. Hyperhidrosis is characterized by excessive sweating that goes beyond normal body temperature regulation, leading to significant impacts on quality of life, including reduced work productivity, disruption of daily activities, emotional distress, and strain on personal relationships. It is the third most prevalent dermatological condition, affecting approximately 10 million individuals in the United States alone. |
| Expected Market Launch Date |
Botanix will commence an early patient experience programme in the third quarter (Q3) of 2024, allowing qualified patients to obtain early access to SOFDRA™.
A broader launch is anticipated in early Q4 2024. |
| New Molecular Entity (NME) or Existing Formulation |
NME |
| Expected Cost |
Unavailable |
| Product Discontinuation |
N/A |
| Clinical Trials |
The approval was based on data from the randomized, double-blind, vehicle-controlled Cardigan I (NCT03836287) and Cardigan II (NCT03948646) trials. These studies assessed the efficacy and safety of sofpironium topical gel in 701 patients aged 10 years and older with primary axillary hyperhidrosis. Patients were randomly assigned to receive either sofpironium gel or vehicle once daily at bedtime for 6 weeks.
In Cardigan I, the mean Hyperhidrosis Disease Severity Measure–Axillary (HDSM-Ax) score at baseline was 3.5, and median gravimetric sweat production (GSP) over 5 minutes at baseline was 214.1mg (sofpironium) vs 228.6mg (vehicle). Results showed 49% of patients treated with sofpironium had at least a 2-point improvement in HDSM-Ax score by day 43, compared to 29% for vehicle (treatment difference, 18% [95% CI, 8-29]). The sofpironium group also had a greater change from baseline in GSP (-128 vs -100).
In Cardigan II, the mean HDSM-Ax score at baseline was 3.6, and median GSP over 5 minutes at baseline was 207.7mg (sofpironium) vs 231.1mg (vehicle). Findings showed 64% of patients treated with sofpironium achieved at least a 2-point improvement in HDSM-Ax score by day 43, compared to 48% for vehicle (treatment difference, 17% [95% CI, 6-27]). The sofpironium group also demonstrated a greater change from baseline in GSP (-143 vs -134). |
| |
Botanix Pharmaceuticals. Sofpironium Bromide. Available at: https://botanixpharma.com/sofpironium-bromide/. Accessed June 21, 2024.
Drugs.com. FDA Approves Sofdra (sofpironium) Topical Gel for Primary Axillary Hyperhidrosis. Available at: https://www.drugs.com/newdrugs/fda-approves-sofdra-sofpironium-topical-gel-primary-axillary-hyperhidrosis-6309.html. Published June 2024. Accessed June 21, 2024.
Sofdra. Available at: https://www.sofdra.com/. Accessed June 21, 2024.
ASX Research. Company Announcement: Botanix Pharmaceuticals. Available at: https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02819259-6A1212299. Published June 2024. Accessed June 21, 2024.
Sofdra. Prescribing Information. Available at: https://www.sofdra.com/pdfs/prescribing-information.pdf. Published June 2024. Accessed June 21, 2024.
Botanix Pharmaceuticals. EP Analyst Note. Available at: https://botanixpharma.com/wp-content/uploads/EP-analyst-Note.pdf. Published June 2024. Accessed June 21, 2024. |