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- Botanix Pharmaceuticals’ (BOT) application to use sofpironium bromide gel to treat primary axillary hyperhidrosis has been knocked back by the US FDA
- A complete FDA review details key issues centred around the need for instructions to use the gel, which is halting approval by 3-6 months
- Botanix will meet with the FDA to address these requirements to resubmit its novel drug application in early 2024, with a targeted approval by mid-2024
- Despite its knockback, Botanix encountered no clinical efficacy, safety, pharmacology, non-clinical, or manufacturing issues during all previous clinical trials
- BOT shares closed 22.2 per cent, trading at 14 cents
Botanix Pharmaceuticals (BOT) has had its application to use the novel sofpironium bromide gel to treat primary axillary hyperhidrosis rejected by the US Food and Drug Administration (FDA).
The clinical dermatology company received a comprehensive review from the FDA, which identified key issues centred around the instructions for using the gel, leading to a delay in its approval by 3-6 months.
The FDA stated that gels require instructions for use, unlike tablets or capsules, which contain the required dosage in a sealed form. This issue can be rectified by incorporating an instruction manual.
Despite this setback, Botanix did not encounter any clinical efficacy, safety, pharmacology, non-clinical, or manufacturing issues during all previous clinical trials. The FDA does not require additional clinical studies to support the approval.
“Importantly, we are now clear on what is required by the FDA, and it is our goal to work with the FDA to address their comments on the patient instructions so that we can resubmit for approval as rapidly as possible,” BOT Executive Chair Vince Ippolito said.
“Primary axillary hyperhidrosis is a medical condition which has debilitating effects on patients and with limited options available in the market, Sofpironium Bromide once approved, will provide a much-needed alternative for this population.”
Botanix has scheduled meetings with the FDA to address all the requirements necessary for approval, with plans to resubmit its novel drug application in early 2024, aiming for approval by mid-2024.
BOT shares closed 22.2 per cent, trading at 14 cents.
