Nitto Denko Corporation (“Nitto Denko”; Head Office: Osaka, Japan; President and CEO: Yukio Nagira)
and Maruho Co., Ltd., (“Maruho”; Head Office: Osaka, Japan; President and CEO: Koichi Takagi)
announced today that Nitto Denko obtained approval of “pain relief in laser irradiation treatment of
the skin” from the Japanese Ministry of Health, Lavour and Welfare (“MHLW”) as an additional
indication for Penles™ Tape 18 mg (generic name: lidocaine), a local anesthetic patch preparation for
which Nitto Denko holds manufacturing and marketing approval, and is sold by Maruho, and which has
already been approved for “pain relief in insertion of venous indwelling needle” and “relief of pain
following removal of molluscum contagiosum.”
Since its launch in the Japanese market in 1994, Penles™ Tape 18 mg has been marketed as a transdermal
local anesthesic containing lidocaine in an easy-to-use patch form.
Laser irradiation is commonly used to treat patients, including many children, with such as pigmented
skin lesions (birthmarks, etc.) and hemangiomas, and often causes pain , which has led to a demand for
a local anesthetic that can be safely and conveniently used with reliable efficacy in clinical
settings.
Nitto Denko and Maruho jointly conducted a series of clinical studies, with patients including
children, on “pain relief in laser irradiation treatment of the skin” using Penles™ Tape 18 mg, and
filed an application for approval of this additional indication to the MHLW.
With the approval of this additional indication, Nitto Denko and Maruho expect that easy-to-use
Penles™ Tape 18 mg will contribute in facilitating “pain relief in laser irradiation treatment of the
skin.”
Nitto Denko and Maruho will continue to listen closely to the opinions of patients and healthcare
professionals, and contribute to better health for people all over the world.
