Shares of Menlo Park, Calif.-based Dermira jumped more than 10 percent this morning after the U.S. Food and Drug Administration (FDA) approved its therapy for people who have excessive underarm sweating.
Shares of Menlo Park, Calif.-based Dermira jumped more than 10 percent this morning after the U.S. Food and Drug Administration (FDA) approved its therapy for people who have excessive underarm sweating.
The FDA gave the green light to Dermira’s topical prescription Qbrexza, which could provide a reduction in excessively sweaty armpits due to primary axillary hyperhidrosis, for nearly 10 million people. The newly approved therapy is expected to be available for patients in October of this year, the company said this morning.
This was good news for Dermira, particularly since the company saw two Phase III failures for its acne treatment olumacostat glasaretil in March. The acne medication failed to meet co-primary endpoints in the late-stage CLAREOS-1 and CLAREOS-2 trials. That failure caused shares to plunge 63 percent. Shares had fallen to $8.78 by Thursday, but with the FDA approval of Qbrexza, shares are slowly climbing. This morning the stock hit a high of $10.79 but has slipped back to $9.36 per share as of 10:07 a.m.
Qbrexza (glycopyrronium) is an anticholinergic indicated for the topical treatment of primary axillary hyperhidrosis in adult and pediatric patients over the age of nine. Primary axillary hyperhidrosis results in sweating beyond what is needed for normal body temperature regulation. Qbrexza is applied directly to the skin and is designed to block sweat production by inhibiting sweat gland activation.
Tom Wiggans, chairman and chief executive officer at Dermira, said they had been told “for years” about the need for a treatment to address primary axillary hyperhidrosis “given the stigma and burden associated with this condition.”
“From the start, our goal was to develop an approach that went beyond masking a person’s excessive underarm sweating and instead focused on treating the condition in a clinically meaningful way. We partnered with dermatologists and the FDA during the development stage and listened to the people who have been living with this condition to understand how they would define a meaningful benefit. It is our hope that Qbrexza will not only provide the clinical benefit these sufferers have been seeking, but help to reduce the overall burden on their lives,” Wiggans said in a statement.
The FDA approval of Qbrexza is based on results from two Phase III clinical trials, ATMOS-1 and ATMOS-2, which evaluated the efficacy and safety of Qbrexza in patients with primary axillary hyperhidrosis. Both trials assessed the absolute change from baseline in sweat production following treatment with Qbrexza and the proportion of patients who achieved at least a four-point improvement from baseline in their sweating severity, as measured by the Axillary Sweating Daily Diary (ASDD). The most common side effects observed following topical application of Qbrexza to the underarms were dry mouth, dilated pupil (mydriasis), sore throat (oropharyngeal pain), headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin and constipation. The most common local skin reactions were erythema, burning/stinging and pruritus.
