Dermira Inc said its experimental topical therapy for excessive underarm sweating was successful in two late-stage studies, bringing it one step closer to providing an easy-to-use therapy for the often embarrassing condition.
While the function of sweating is to prevent overheating, those affected sweat even when the body does not need cooling.
Existing therapies for excessive underarm sweating, also called axillary hyperhidrosis, offer limited effectiveness and can be expensive.
The first line of defense are anti-perspirants. Next, patients can try costlier alternatives such as botox injections, a device called miraDry that delivers electromagnetic energy to decompose sweat glands, or laser therapy to destroy them.
Sufferers can also opt for localized surgery, like liposuction, to remove or injure sweat glands. Oral medicines can be used to systemically limit sweating. For instance, a class of drugs called anticholinergics are commonly used off-label for this purpose, but they are linked with the risk of dementia.
Based on the most recent estimates, about 7.8 million Americans have some form of excessive sweating including palms, feet, underarms or head, and about half of this population suffer from the underarm form, said Dermira spokeswoman Erica Jefferson, in an interview ahead of the data readout.
The Menlo Park, California-based company’s shares were up 3 percent at $33.00 in extended trading on Wednesday.
About two-thirds of the total 697 enrolled in the two trials for the company’s topical treatment, DRM04, were treated with wipes containing DRM04, while the rest were not.
In the first trial, a significant improvement in the severity of sweating was seen in 52.8 percent of the patients treated with the drug, compared with 28.3 percent patients in the control group, on a scale designed by the company.
In the second trial, a significant improvement was seen in 66.1 percent of the drug-treated patients, compared with 26.9 percent in the control group.
Dermira said it had expected to apply for marketing approval for the drug in the second half of 2017, subject to completion of the drug’s long-term safety trial.
(Reporting by Natalie Grover and Shailesh Kuber in Bengaluru; Editing by Maju Samuel)
This is a brief story about two studies of a topical skin treatment for excessive sweating, directed at an investor/financial audience.
The story has several major deficiencies, the most egregious being the lack of any specific, useful details of the new treatment, and the research so far conducted on it. We actually found the drug company’s news release to be more informative.
The story borders on disease mongering as well, since few details are given what makes this condition more than just a variation of a normal state of health.
While it may not be a disease per se, excessive sweating can be an embarrassing condition to live with, and new topical treatments would likely be welcomed by people who want to avoid oral medications, injections or surgery.
The product is not yet on the market, and is defined as experimental, so we’ll rate this as N/A. But readers would still benefit from seeing the projected steps needed to get on the market, which isn’t made clear here.
Not enough detail is contained in the description of the drug’s benefits: “a significant improvement in the severity of sweating was seen in 52.8 percent of the patients treated with the drug, compared with 28.3 percent patients in the control group, on a scale designed by the company. (and 66.1 percent versus 26.9 percent in the control group in the second trial).
How are we to know what this means when we don’t know how “improvement” or “severity” is measured?
No harms are mentioned, and given the lack of details on what the topical medication is made of, it would be difficult find out via independent research.
The story didn’t include enough information on the quality of the evidence. For example, how valid and reliable is the proprietary scale the drug company created to measure sweating? What are the measurement tool’s limitations? And the studies’ limitations? Also, the story didn’t indicate that this data hasn’t been reviewed by independent experts, nor published in a peer-reviewed journal.
We’re told in the story that about 3.9 million Americans suffer from excessive underarm sweating. But based on what analysis? What’s the source for that figure, and is it trustworthy?
A spokesperson from the company is quoted. However, no independent sources are used.
Many alternatives are mentioned, and that’s enough to skirt by as Satisfactory.
However, the discussion of alternatives (such as antiperspirants and Botox injections) seems mostly to revolve around pointing out how problematic they are, without any discussion of actual comparative effectiveness, which is a disservice to readers.
We learn it is still in its experimental stages.
The story makes no unfounded claims about novelty, and the story makes it clear that an effective topical treatment via wipes would be new for this condition.
The story didn’t appear to rely primarily on the news release, as we don’t see signs of quotes or text being lifted directly without acknowledgment. We’ll rate this N/A.
However, the release does have additional valuable context that we wish had been included (with acknowledgement), such as study details and adverse effects of the medication.