Dermira's DRM04 Shows Promise for Primary Axillary Hyperhidrosis

06/01/2016

Dermira’s DRM04 may help put the brakes on primary axillary hyperhidrosis, according to topline results from two Phase 3 trials.

Based on the results of these trials, Dermira plans to submit a New Drug Application to the US Food and Drug Administration for potential approval of DRM04 in the second half of 2017.

DRM04, a investigational topical anticholinergic product, blocks sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.

In ATMOS-1, 229 patients were randomized to receive DRM04 and 115 patients were randomized to receive vehicle. The proportion of patients who achieved at least a four-point improvement in sweating severity, as measured by the Axillary Sweating Daily Diary (ASDD), was 52.8 percent in DRM04-treated patients, compared to 28.3 percent in patients who received the vehicle only (p<0.001). What’s more, the average reduction in sweat production was 104.9 mg in patients treated with DRM04 as compared to 91.9 mg in vehicle-treated patients based on the overall dataset from the intent-to-treat population (p=0.065).

In ATMOS-2, 234 patients were randomized to receive DRM04 and 119 patients were randomized to receive vehicle. The proportion of patients who achieved at least a four-point improvement in sweating severity, as measured by the ASDD, was 66.1 percent in DRM04-treated patients, compared to 26.9 percent in patients who received the vehicle only (p<0.001).  The average reduction in sweat production was 110.3 mg in patients treated with DRM04 as compared to 92.2 mg in patients who received the vehicle only (p<0.001). 

Consistent with the results from the Phase 2 clinical program, DRM04 was generally well-tolerated with side effects that were primarily mild to moderate in severity. The most frequently reported adverse events were dry mouth, application site pain, dilated pupil, headache, sore throat, upper respiratory tract infection, blurred vision, urinary hesitation and dry eye .

Dermira is also conducting ARIDO, an open-label trial assessing the long-term safety of DRM04 as part of its Phase 3 program to provide safety data for a minimum of 100 patients who have received DRM04 for at least 12 months per the International Council on Harmonization guidelines. Patients from the ATMOS-1 and ATMOS-2 trials were permitted to enroll in the ARIDO trial and continue to receive DRM04 (active treatment) for up to an additional 44 weeks from the end of the four-week treatment periods in the ATMOS-1 or ATMOS-2 trials. A total of 564 patients, elected to enroll in ARIDO. Dermira expects to complete the treatment period for the ARIDO trial by the end of 2016.

 

 

 

 

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