Dermira announced that the Food and Drug Administration (FDA) has approved Qbrexza (glycopyrronium) cloth for the topical treatment of primary axillary hyperhidrosis in patients aged ≥9 years.
Qbrexza is a topical anticholinergic that acts as a competitive inhibitor of acetylcholine receptors located on sweat glands, thus reducing sweating.
The approval was supported by Phase 3 data from the ATMOS-1 and ATMOS-2 trials which evaluated the absolute change from baseline in sweat production after treatment with Qbrexza, and the proportion of patients who achieved ≥4-point improvement from baseline in their sweating severity (as measured by the Axillary Sweating Daily Diary [ASDD]). Patients were randomized to receive either Qbrexza or vehicle applied once daily to each axilla.
In ATMOS-1, 53% achieved a ≥4-point improvement from baseline in mean ASDD item #2 at week 4 vs 28% in the vehicle group. Also, there was a greater change from baseline in sweat production at week 4 in the Qbrexza group vs vehicle (median -81mg/5mins vs -66mg/5mins). In ATMOS-2, 66% achieved a ≥4-point improvement from baseline in mean ASDD item #2 at week 4 vs 27% in the vehicle group. The change from baseline in sweat production at week 4 was also greater in the Qbrexza group vs vehicle (median -79mg/5mins vs -58mg/-5mins).
Dry mouth, mydriasis, oropharyngeal pain, headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin, and constipation were among the most frequently reported side effects.
Qbrexza will be available as 2.4% pre-moistened single-use cloths in 30-count pouches. It is anticipated to launch in October 2018.
For more information call (877) 337-5553 or visit Qbrexza.com.