The NHI Drug Reimbursement Price Listing and Launch of ECCLOCK Gel 5% for the Treatment of Primary Axillary Hyperhidrosis

Tokyo, November 18, 2020 - Kaken Pharmaceutical Co., Ltd., ("Kaken") announced that ECCLOCK® Gel 5% (INN: sofpironium bromide, code name: BBI-4000, "ECCLOCK®") for the treatment of primary axillary hyperhidrosis was listed on the National Health Insurance (NHI) drug reimbursement price list in Japan. Kaken also plans to launch ECCLOCK® on November 26, 2020.

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.

Kaken will contribute to improving the quality of life for more patients by providing a new treatment option for primary axillary hyperhidrosis.

[Product overview]

Trade name: ECCLOCK® Gel 5%

INN: Sofpironium bromide

Indications: Primary axillary hyperhidrosis

Dosage and Administration: Apply an appropriate amount to the axillae once a day.

Date of Approval: September 25, 2020

Date of NHI Drug Price Listing: November 18, 2020

NHI Drug Price: 243.70 yen/g (20 g/bottle: 4,874.00 yen)

*Please refer to the latest package insert and interview form for details.

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 Hyperhidrosis Disease Severity Scale (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

1.Strutton DR, et al.: J Am Acad Dermatol 2004; 51(2): 241-248.

To read more Press Release articles, click here.