(Ref: Kaken)
September 25th, 2020
Tags: Press Release Ecclock Brickell Biotech Kaken Marketing & Sales Regulatory Affairs
Tokyo, September 25, 2020 - Kaken Pharmaceutical Co., Ltd., ("Kaken") announced that it has obtained approval of ECCLOCK® Gel 5% (INN: sofpironium bromide, code name: BBI-4000, "ECCLOCK®") in Japan for primary axillary hyperhidrosis.
ECCLOCK® is the first topical product in Japan approved for the treatment of primary axillary hyperhidrosis, which is classified as an anticholinergic agent that inhibits the action of acetylcholine, a neurotransmitter. Acetylcholine is thought to induce sweating by binding to muscarinic receptors at the sweat glands. Sofpironium bromide, an active ingredient of ECCLOCK®, inhibits the binding of acetylcholine by binding to muscarinic receptors in the eccrine sweat glands that cause hyperhidrosis, thereby reducing sweating. Applying it once a day to both the axillae can be effective. An applicator (application tool) included with the container-closure system of the product allows the drug application without the hands touching the product.
In March 2015, Kaken acquired the exclusive rights to the development, manufacture, and marketing in Japan and certain other Asian countries from Brickell Biotech, Inc., based in Colorado, USA ("Brickell"), for sofpironium bromide, and has developed as a topical drug product in Japan. ECCLOCK® Gel 5% is approved based on the results of the Phase 3 study in Japan. The multicenter, randomized, double-blind, vehicle controlled confirmatory study was designed to evaluate the efficacy and safety of ECCLOCK® Gel 5% vs. vehicle administered for 6 weeks in 141 and 140 subjects with primary axillary hyperhidrosis. The results showed that the primary endpoint—the percentage of subjects with an HDSS of 1 or 2 and ≥50% reduction in the gravimetric sweat production from baseline to end of treatment (week 6) for both axilla—showed significant improvement in ECCLOCK® Gel 5% group compared to the vehicle group. The main adverse events related to study drug were dermatitis, erythema, or pruritus at the application site.
In the meantime, Brickell plans to initiate a Phase 3 study in the United States in the fourth quarter of 2020.
Kaken will contribute to improving the quality of life for more patients by providing a new treatment option for primary axillary hyperhidrosis.
About Primary axillary hyperhidrosis
A condition that involves heavy sweating under the armpits caused by heat, stress, or occurring without such causes, and interferes with daily life and work.
About HDSS
Hyperhidrosis disease severity score (HDSS) is the scale to assess the severity of hyperhidrosis based on subjective symptoms and is a score that is classified into four categories from 1 to 4, depending on the patient's reported outcomes. A score of 3 or 4 is considered an indicator of severe illness.1
Strutton DR, et al.: J Am Acad Dermatol 2004; 51(2): 241-248.
Bron: https://www.firstwordpharma.com/node/1760439?tsid=33
Toegestaan in Japan dus al, nu wachten op de FDA in de USA en dan hopelijk snel naar Europa!
