- Botanix Pharmaceuticals’ (BOT) lead product, Sofpironium Bromide, passes an FDA mid-cycle review
- The FDA detected no safety issues and no risk management issues or board requirements in the review of the Botanix product
- BOT says it will now continue discussions with the FDA around labelling, clinical outcome assessments, patient instructions and a brand name for its product
- The planned approval date for Sofpironium Bromide remains on track for September 2023
- BOT has called a trading halt ahead of a planned capital raise, and shares last traded at 10 cents
Botanix Pharmaceuticals’ (BOT) lead product, Sofpironium Bromide, had passed a US Food and Drug Administration (FDA) mid-cycle review.
The company said the FDA detected no safety or risk management issues in the review of the Botanix product.
According to the FDA, Sofpironium Bromide displayed no evidence of clinical safety risk and has received no risk management or board requirements.
Botanix said this meant its planned approval date for Sofpironium Bromide remained on track for September 2023.
BOT said it would now continue discussions with the FDA around labelling, clinical outcome assessments, patient instructions and a brand name for its product.
The company will also continue to work with the FDA to respond to information requests, review their further comments and facilitate inspections for the approval process to move forward.
Botanix’s lead product is designed to treat axillary hyperhidrosis — a condition causing excessive sweating.
BOT has called a trading halt ahead of a planned capital raise, and shares last traded at 10 cents.