Twyneo, a tretinoin and benzoyl peroxide cream, has been approved by the FDA for the treatment of acne vulgaris in patients 9 years and older.
Today Sol-Gel Technologies, Ltd. announced that the FDA has approved Twyneo (tretinoin/benzoyl peroxide) cream, 0.1%/.3% as a treatment of acne vulgaris in patients 9 years and older.1 The New Drug Application (NDA) form was approved on July 26.
The cream uses Sol-Gel’s technologies to capture tretinoin and benzoyl peroxide within silica-based microcapsules to stabilize the tretinoin from degradation caused by benzoyl peroxide. This process slowly releases the active ingredients over time for efficacy and safety.
“The FDA approval of Twyneo underscores our ability to deliver innovative, proprietary drugs to the market,” said Alon Seri-Levy, PhD, co-founder and CEO of Sol-Gel. “Based on the clinical data observed, we believe that Twyneo has the potential to change the treatment landscape for the tens of millions of patients suffering from acne vulgaris. With market leader, Galderma, handling the product launch of Twyneo, we are excited that Twyneo will soon be available to patients in the US,” said Seri-Levy.
This approval is based on 2 phase 3, multicenter, double-blind, randomized, parallel-group, and vehicle-controlled studies (NCT03761784 and NCT03761810), evaluating the safety and efficacy of Twyneo as a potential treatment for acne vulgaris.
Both studies met all primary endpoints. The trials examined absolute change in baseline at week 12 in inflammatory and non-inflammatory lesion count, as well as a proportion of patients who achieved at least a 2-grade reduction from the baseline and attained a clear or almost clear rating at week 12 on the Investigator Global Assessment (IGA) scale.
During the studies, 858 subjects 9 years and older with moderate to severe acne vulgaris were treated in a randomized fashion with either the vehicle cream (n=287) or Twyneo (n=571) once daily for 12 weeks.
Results of the studies demonstrated in the first trial (NCT03761784), 38.5% of patients treated with Twyneo achieved IGA success compared to 11.5% in the vehicle group. Additionally, the other study (NCT03761810) found 25.4% of Twyneo patients achieved the 2-grade reduction on the IGA scale compared to 14.7% of patients treated with vehicle.
The treatment displayed a -21.6-absolute change in the baseline of inflammatory lesion count versus -14.8 for the vehicle group in the first trial. While data from the second trial showed a -16.2 absolute change in the baseline of inflammatory lesion count with Twyneo compared to -14.1 in the vehicle group.
Similar results were found in the absolute change in the baseline of non-inflammatory lesion count, as NCT03761784 demonstrated a -29.7 for patients treated with Twyneo and -19.8 in patients the vehicle group and NCT03761810 was -24.2 for Twyneo versus -17.4 for the vehicle.
Twyneo is patent protected until 2038 and Sol-Gel has partnered with Galderma to sell to the US market, with Sol-Gel retaining the option to regain US commercialization rights 5 years after the first commercialization in the US.
This is the first time tretinoin and benzoyl peroxide has been combined into a treatment cream. Sol-Gel plans to have its other drug, Epsolay (benzoyl peroxide), approved soon as it was delayed due to COVID-19.
1. Ltd S-GT. Sol-gel technologies announces FDA approval of Twyneo®. GlobeNewswire News Room. Published July 27, 2021. Accessed July 27, 2021. https://www.globenewswire.com/news-release/2021/07/27/2269561/0/en/Sol-Gel-Technologies-Announces-FDA-Approval-of-TWYNEO.html