Botanix Pharmaceuticals successfully completes human factors validation study for Sofdra

Botanix Pharmaceuticals Limited (ASX: $BOT) has successfully completed the planned human factors validation study assessing the revised Instructions for Use (IFU) for Sofpironium Bromide gel, 15% ('Sofdra™'). The study confirmed that all participants successfully prepared and applied Sofdra in accordance with the revised IFU. The Company will now prepare to resubmit the Sofdra new drug application ('NDA') to FDA in 1Q CY 2024, targeting FDA approval in mid-CY2024.

Botanix CEO, Dr Howie McKibbon, on the successful completion of the HF Study

We are very pleased with the outcome of the HF Study for Sofdra and the performance of the revised IFU, in guiding patients to the safe and successful use of the product. The team will continue working over the holiday break to expeditiously assemble materials for resubmission, to allow a rapid turnaround and filing with FDA for Sofdra approval.

Botanix Pharmaceuticals outlook and ambitions

Botanix Pharmaceuticals has successfully completed the human factors validation study for Sofdra, positioning the Company to prepare for the resubmission of the NDA to FDA with the revised IFU. The Company aims for FDA approval in mid-CY2024. Additionally, Botanix is on track with commercial launch preparations for Sofdra in the United States, focusing on engaging US payers, preparing launch marketing and sales materials, testing telemedicine and supply chain elements, and finalizing sales strategies. Botanix Pharmaceuticals is also progressing its pipeline of other products in late-stage clinical studies for the treatment of moderate to severe rosacea, dermatitis, and acne, as well as developing a topical antimicrobial product for the eradication of bacteria on the skin surface.