No sweat for dermatology specialist Botanix as hyperhidrosis gel Sofdra gains FDA approval

Preview

来源: FiercePharma

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.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。