Lindmik Research I Jiuguang Pharmaceutical's First Transdermal Preparation Approved for the Treatment of Primary Palmar Hyperhidrosis

Click:433  Update time：2023-04-21  【Close】

ABSTRACT

On March 27, 2023, Japan's Jiuguang Pharmaceutical Co., Ltd. (headquartered in Bird's Nest City, Saga Prefecture, Japan; President and CEO: Kazuhide Nakatomi) announced that it had obtained APOHIDE ® Lotion, with 20% production and sales approval, is the first drug in Japan to treat hand sweating (R&D code: HP-5070, generic name: Oxibunin Hydrochloride, hereinafter referred to as "this product").

Primary palmar hyperhidrosis is a disease characterized by excessive palmar sweating and is known to be a major factor in reducing the quality of life and labor efficiency in various aspects of school and social life, as it can seriously interfere with social activities (such as shaking hands, clerical work, and electronic device operation)。

This product is an topical topical formulation developed using Jiuguang's TDDS (transdermal delivery system) technology, and is the first drug in Japan to demonstrate efficacy and safety in phase III clinical studies targeting patients with primary palmar hyperhidrosis.

With this approval, Jiuguang Pharmaceutical expects the product to be applied to the palm of the hand once a day before bedtime, which will become a new choice for treating primary palmar hyperhidrosis.

Attached product production and marketing license notice:

Source (Network)

Basic Product Information

Product:APOHIDE ^® Lotion 20%

Main ingredient: Oxybutin hydrochloride
Indications: Primary palmar hyperhidrosis
Usage and dosage: Once a day before bedtime, take an appropriate amount onto both palms.
Attention: One application should be equivalent to five pump strokes per palm of both hands.
Packaging specification: 4.5mL (plastic container) x 20 bottles

来源(网络)

Three topical anticholinergic drugs for primary hyperhidrosis as of March 2023

Product name	Sofelonium bromide gel 5%	Gelong ammonium bromide napkin 2.5%	Oxibunin lotion 20%
Common name	Sofirolomide bromide	GLYCOPYRROLATE	Oxybutynin
Effectiveness	Primary axillary hyperhidrosis		Primary palmar hyperhidrosis
Usage and dosage	Once a day, apply an appropriate amount to the armpit.	Once a day, one package contains a piece of non-woven fabric, and the solution is applied to both armpits.	Once a day, apply an appropriate amount to the palms of both hands before going to bed (with the target of pressing the pump head 5 times on both palms).
Taboo	·Angle closure glaucoma； ·Urinary disorders caused by prostate enlargement; ·Previous history of allergies to the ingredients of this preparation.		·Angle closure glaucoma; ·Urinary dysfunction caused by lower urinary tract occlusion disease (prostate enlargement, etc.); ·Severe heart disease; ·Intestinal obstruction or paralytic intestinal obstruction; ·Myasthenia gravis; ·Previous history of allergies to the ingredients of this preparation.
Specific background patient precautions	·Specific background patient precautions: Prostate hypertrophy (excluding urinary disorders), trauma, eczema, dermatitis, etc. can be seen at the application site.		·Specific background patient precautions: Prostate hypertrophy (excluding urinary disorders), hyperthyroidism, congestive heart failure, arrhythmia, ulcerative colitis, Parkinson's symptoms or cerebrovascular disorders, dementia or cognitive impairment, trauma, eczema, dermatitis, etc. can be seen at the application site; ·Severe renal dysfunction; ·Severe liver dysfunction.
Mother-to-be	·Administer only when it is judged that the therapeutic benefits outweigh the risks		·Suggest not to use
Children	·Not allowed to use under the age of 12	·Not allowed to use under the age of 9	·Not allowed to use under the age of 12

Last:Lindmik Research I FDA Update General Transdermal and Local Drug Delivery System Guidelines
Next:Sinopharm Holdings and Leming Pharmaceutical jointly sign a strategic cooperation agreement