Patients suffering from axillary hyperhidrosis, a condition characterised by excessive sweating, may need to wait another 6 months for the treatment developed by dermatology company Botanix Pharmaceuticals (ASX: BOT) with US regulators not satisfied with the instructions provided alongside the treatment.

The United States Food and Drug Administration (FDA) has issued a letter to Botanix, outlining that the instructions need to be reprinted, but more importantly that another short human factors validation study be conducted before Botanix can resubmit their New Drug Application (NDA).

The process is expected to delay the launch of Sofpironium Bromide gel by 3-6 months.

The sole point of contention identified in the FDA’s Letter revolves around the “Instructions for Use” of Sofpironium Bromide. These instructions are essential for patients to safely and effectively apply the gel, which comes in a pump and is administered using an applicator.

Botanix had, prior to submission, conducted human factors studies to validate these instructions, involving volunteers who followed the instructions to demonstrate correct application. Despite these efforts, the FDA found the instructions lacking and called for additional edits to the document. The exact edits or reasoning have not been disclosed by Botanix.

The FDA did not identify any other deficiencies in the NDA. The safety and efficacy of Sofpironium Bromide, supported by highly statistically significant results from two Phase 3 studies and a long-term safety study, were not in question. No new clinical trials or manufacturing changes are needed for resubmission, placing the focus solely on patient instructions, which may incur additional costs than originally budgeted.

Botanix’s Executive Chairman, Vince Ippolito, expressed disappointment at the delay but conveyed confidence in the initial submission, data, and future resubmission.

“Importantly, we are now clear on what is required by the FDA, and it is our goal to work with FDA to address their comments on the patient instructions, so that we can resubmit for approval as rapidly as possible,” said Ippolito.

“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.”

The company aims to resubmit the NDA in early 1Q CY2024, with a target approval date in mid-CY2024.

The delay in the launch of Sofpironium Bromide is expected to postpone Botanix’s commercialisation plans by 3-6 months. However, the company remains optimistic about the market opportunity for its product, as it addresses a pressing medical need. In the United States alone, an estimated 3.7 million patients are currently being treated for primary axillary hyperhidrosis, with approximately 10 million individuals affected by the condition.