Catalyst

Slingshot members are tracking this event:

Allergan Announces FDA Approval of ACZONE (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris

Do you think this event is important to the companies below? How will it affect their stock price?

Related Companies
Importance
High Medium Low
Impact on Stocks
AGN Community voting in process

Additional Information

Additional Relevant Details Allergan has received approval from the U.S. Food and Drug Administration (FDA) to market ACZONE (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older. ACZONE Gel, 7.5% delivers proven efficacy to treat both inflammatory and non-inflammatory acne, with a new concentration of dapsone in just once-a-day application.In clinical trials of ACZONE Gel, 7.5%, safety and efficacy were assessed in two identically designed, randomized, multi-centered, double-blind, vehicle-controlled 12-week studies. A total of 4,340 acne patients were randomized to receive either ACZONE Gel, 7.5% (n=2162) or vehicle (n=2178). The majority of patients (99%; n=4339) had moderate acne, with a baseline score of 3 on the Global Acne Assessment Score (GAAS). ACZONE Gel, 7.5% was approved based on co-primary endpoints of the GAAS and lesion counts (20 to 50 inflammatory and 30 to 100 non-inflammatory lesions at baseline). At week 12, inflammatory lesions were reduced by 15.8 lesions (54.6%; n=2162) vs 13.9 lesions with vehicle (48.1%; n=2178), and non-inflammatory lesions were reduced by 20.7 lesions (45.1%) vs 18.0 lesions with vehicle (39.4%).2 The GAAS success rate in patients was 29.8% (n=2162) vs 21.1% with vehicle (n=2178).2 In addition to efficacy, ACZONE Gel, 7.5% has a proven tolerability profile. Out of 2161 patients who used ACZONE Gel, 7.5%, 1.1% experienced mild application-site dryness vs 1.0% with vehicle (n=2175), and 0.9% experienced pruritus vs 0.5% with vehicle.



http://www.allergan....
Slingshot Insights Explained
Catalyst Date
Occurred on:
Feb 25, 2016
Related Projects Image
  • Don’t see a project related to the catalyst you care about?

Related Keywords Aczone, Dapsone, Acne Vulgaris, Pump Delivery System