For Dermira Inc., winning the FDA's nod for Qbrexza (glycopyrronium cloth) as the first once-daily, topical treatment for primary axillary hyperhidrosis is only step one in its commercialization challenge. The Menlo Park, Calif.-based dermatology-focused firm now is tasked with reaching the nearly 10 million people estimated to suffer from the condition, more commonly known as excessive underarm sweating, many of whom have given up on ever finding a treatment.

Dermira's chairman and CEO, Tom Wiggans, described some of the company's market research over the last two to three years during the Jefferies Global Healthcare Conference in early June. "The answer we got back from the first market research report was the good news is there's a lot of patients out there and they are desperate; the bad news is that they gave up years ago," he said.

The company already has started exploring social media and has tapped a consumer outreach spokesperson to help with direct-to-consumer efforts. It also launched a disease awareness campaign earlier this year. The approach is three-pronged, according to Wiggans: educating physicians, gaining coverage for Qbrexza and getting patients to come back in to see their doctors – "how do we get them to re-engage?" he said.

Dermira seeks to launch Qbrexza in October. Specific pricing has not been disclosed, but Wiggans has said the firm estimates pricing along the same lines as other branded dermatology products, putting in somewhere between $300 and $700 per month.

Developed in a cloth wipe format, Qbrexza is applied directly to the skin and is designed to block sweat production via antagonism of the cholinergic receptor, inhibiting sweat gland activation.

That ease of administration is likely to be a big selling point. While limited treatment options exist for hyperhidrosis, Botox (onabotulinumtoxin type A, Allergan plc) is cleared for that indication, and, according to Evercore ISI analysts, it has a roughly $70 million run rate, though shows no real growth in that indication, which may be at least in part due to administration. Botox is administered via injection.

"Dermira will have to work hard on creating this market," Evercore's Umer Raffat wrote in a research note.

The company currently estimates that maybe 5 million patients have talked to their doctors, though only 15 percent might actually receive any kind of treatment.

"I have to admit: I was in the more skeptic camp on unmet need for drug treatments in hyperhidrosis ... until I saw a workshop hosted by FDA where I listened to many patient stories about the social stigma/unsuccessful job interviews, etc.," he added.

Qbrexza's approval, which was largely expected ahead of the June 30 PDUFA date, was based on results from two phase III trials, ATMOS-1 and ATMOS-2, which measured the absolute change from baseline in sweat production – defined as the weight or amount of sweat a patient produced – following treatment and the proportion of patients achieving a least a four-point improvement from baseline in their sweating severity, as assessed by the Axillary Sweating Daily Diary, a patient-reported outcome instrument devised by Dermira and developed in accordance with FDA guidance. (See BioWorld Today, June 3, 2016.)

The FDA's label includes use in adult and pediatric patients as young as 9, which Mizuho Securities analyst Irina Koffler called "encouraging," though she pointed to some side effects – namely itching (8.1 percent) and burning/stinging (14/1 percent) – in the label, "which may deter some patients, in our view."

Analysts did not expect much movement in Dermira's stock (NASDAQ:DERM) based on the approval, and there wasn't: Shares closed Friday at $9.20, up 42 cents.

Most eyes are on Dermira's atopic dermatitis program, given its potential blockbuster opportunity. Lebrikizumab, an IL-13 antagonist acquired from Roche Holding AG last year in a $1.4 billion deal, started a phase IIb dose-ranging trial in adults with moderate to severe disease early this year, with the aim of optimizing the dose for design of a phase III program. (See BioWorld, Aug. 9, 2017.)

In March, the company reported disappointing data from its lead acne product, DRM-01 (olumacostat glasaretil), which failed to mirror promising results in earlier midstage studies. In its first-quarter earnings, Dermira said it expected to discontinue the program. (See BioWorld, March 6, 2018.)