- Botanix Pharmaceuticals (ASX:BOT) completes the planned HF validation study for Sofdra, evaluating revised instructions for use
- All participants in the HF study prepared and applied Sofdra according to the revised IFU
- Botanix is moving forward with resubmitting Sofdra to the US Food and Drug Administration
- BOT is hoping for FDA approval to use Sofdra for the treatment of primary axillary hyperhidrosis by the middle of next year
- BOT shares last traded at 15.3 cents
Botanix Pharmaceuticals (ASX:BOT) has completed the planned human factors (HF) validation study for Sofdra, evaluating revised instructions for use (IFU).
All participants in the HF study prepared and applied Sofdra according to the revised IFU, prompting Botanix to move forward with resubmitting Sofdra to the US Food and Drug Administration (FDA).
This resubmission will include the updated IFU, the HF validation study report, and all other requested materials.
“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,” Botanix CEO Dr Howie McKibbon said.
“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 remains firmly on track to submit the final component of the FDA’s approval request by the first quarter of 2024, aiming for approval by mid-year.
BOT shares last traded at 15.3 cents.