Sofpironium Bromide

Hyperhidrosis is the third largest dermatology market behind acne and atopic dermatitis, according to Botanix. Everybody sweats, but for the 10 million people in the U.S. living with primary axillary hyperhidrosis, sweating can take on a whole new meaning. The condition is hallmarked by sweating beyond the level necessary to regulate body temperature. Primary axillary hyperhidrosis specifically refers to the underarms and has major effects on quality of life, potentially impacting patients' work productivity, social interactions and emotional well-being. It’s been years since a new treatment hit the market in this condition. With an FDA approval in hand, Botanix hopes its topical gel Sofdra can change the game. The drug won FDA approval to treat primary axillary hyperhidrosis in patients ages 9 and older. It’s the first and only new chemical entity cleared for the condition, Botanix said in a press release. Current treatment options include AbbVie’s Botox injections and different formulations of glycopyrrolate. Many of the marketed therapies aren’t as targeted as Sofdra so they can dry out other fluids, such as tears, saliva and even cause urinary retention, Botanix’s founder and board executive director, Matt Callahan, said in a recent interview. In two phase 3 studies that enrolled a total of 701 patients, the gel helped patients achieve clinically and statistically meaningful improvements from baseline levels in the Gravimetric Sweat Production scale and the Hyperhidrosis Disease Severity Measure-Axillary score, according to the company's release. Reaching the roughly 10 million U.S. patients with primary axillary hyperhidrosis will require a unique commercial approach for Botanix, especially considering that fewer than half of patients have an official diagnosis, according to the company. Bearing in mind the social challenges the condition presents, many patients may be actively searching online to find a treatment, as opposed to visiting the dermatologist’s office, Callahan said. Botanix will reach these patients through a “very strong digital approach” that includes a telemedicine component. “This is kind of one of those areas where people don't like to talk about it much and dermatologists don't seem to know much about it,” Callahan explained. “So we're trying to solve that problem with a telemedicine approach to provide a better service and a better fulfillment option to these patients.” Still, the large patient population makes for a “massive opportunity” for Botanix, the executive said. Sofrda is the Australia-based company’s first commercial product. It will come with a price tag “on par” with other treatments on the market, but the key difference, Callahan said. Prescription wipe Qbrexza has an average retail price of $771, according to GoodRx.   Considering 90% of those with hyperhidrosis also suffer from excessive sweating in other areas of the body, there is “lots of future potential” from a label expansion perspective, Callahan noted. Callahan says Botanix is something of a “hidden gem” on the Australian Stock Exchange, but the drugmaker plans to become “the next big dermatology company in the U.S.," he added. Its U.S. operations are based in Pennsylvania and Arizona, and the company is also working on treatments for acne and rosacea. The approval makes for a “transformative event” for the company as it transitions “from a development stage to a revenue-generating dermatology company,” CEO Howie McKibbon, M.D., added in Botanix's release. The drugmaker will roll out initial doses through an early patient experience program during this year’s third quarter. The wider launch is expected to take off during the fourth quarter.

The treatment is indicated for usage in adults and children aged nine years and above. Credit: BongkarnGraphic / Shutterstock. Botanix Pharmaceuticals has announced the receipt of approval from the US Food and Drug Administration (FDA) for Sofdra (sofpironium) gel, 12.45%, for excessive underarm sweating (primary axillary hyperhidrosis). The treatment is indicated for usage in adults and children aged nine years and above. Sofdra is the first and only new chemical entity to receive approval in the US  for this condition. The FDA’s decision was based on the results from the two Phase III CARDIGAN studies in 701 patients. The trials assessed the efficacy and safety of Sofdra versus vehicle in primary axillary hyperhidrosis patients. See Also: SGNB-7H4V by Pfizer for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer): Likelihood of Approval SGNB-7H4V by Pfizer for Epithelial Ovarian Cancer: Likelihood of Approval Sofdra met all primary and secondary endpoints, demonstrating significant changes from baseline in Gravimetric Sweat Production (GSP) and the Hyperhidrosis Disease Severity Measure-Axillary, 7-item (HDSM-AX7) score. Botanix will commence an early patient experience programme in the third quarter (Q3) of 2024, allowing qualified patients to obtain early access to Sofdra. This programme will support patients through telemedicine and the payer reimbursement process, making them the first to use Sofdra commercially. A broader launch is anticipated in early Q4 2024. Botanix CEO Dr Howie McKibbon stated: “We are pleased to share this accomplishment with our dedicated Botanix team and dermatologist partners, patients who participated in the clinical studies and our shareholders who made this approval possible. “This is a transformative event for Botanix as we transition from a development stage to a revenue-generating dermatology company.” Botanix executive chairman Vince Ippolito stated: “We are very excited to provide a new option for the 10 million patients with primary axillary hyperhidrosis in the United States.” “As the first and only new chemical entity, Sofdra represents a new therapeutic approach for dermatologists to treat patients with this disabling medical condition.”