Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis
| العنوان: | Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis |
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| المؤلفون: | Richard D. Mamelok, Janice Drew, Edward Lain, Diane R. Mould, David M. Pariser |
| المصدر: | Clinical Pharmacokinetics |
| بيانات النشر: | Springer Science and Business Media LLC, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Adult, Adolescent, medicine.drug_class, Population, Muscarinic Antagonists, Axillary hyperhidrosis, Cholinergic Antagonists, Young Adult, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Pharmacokinetics, medicine, Anticholinergic, Humans, Hyperhidrosis, Pharmacology (medical), Original Research Article, Child, education, Adverse effect, Glycopyrrolate, Aged, Pharmacology, education.field_of_study, business.industry, Middle Aged, Dry mouth, 030220 oncology & carcinogenesis, Anesthesia, Axilla, medicine.symptom, business |
| الوصف: | Background Glycopyrronium tosylate (GT; Qbrexza® [glycopyrronium] cloth, 2.4%) is a topical anticholinergic approved (USA) for primary axillary hyperhidrosis in patients aged ≥ 9 years. Objective The objective of this study was to compare the pharmacokinetics and safety of GT to oral glycopyrrolate (phase I study) and assess the relationship between glycopyrronium pharmacokinetics and anticholinergic-related adverse events or efficacy with population pharmacokinetics using data from two phase II studies. Methods In the phase I study, study staff applied GT to axillae of patients with primary axillary hyperhidrosis (aged 9–65 years) once daily (5 days); oral glycopyrrolate was administered to healthy adults (aged 18–65 years) every 8 hours (15 days). In the phase II studies (NCT02016885 [20 December, 2013], NCT02129660 [2 May, 2014]), adults with primary axillary hyperhidrosis applied topical glycopyrronium (0.8–3.2%) or vehicle to axillae once daily (4 weeks). Pharmacokinetic and adverse event data were collected in all studies. Results Glycopyrronium pharmacokinetic parameters were similar between adult and pediatric patients treated with GT; there was no evidence of accumulation. Systemic absorption of glycopyrronium was lower with GT vs oral glycopyrrolate. No anticholinergic-related adverse events occurred with GT in the phase I study, while dry mouth and nasal dryness occurred with oral glycopyrrolate; anticholinergic adverse events occurred in the phase II studies. In the population pharmacokinetic analysis, frequency/severity of anticholinergic-related adverse events increased with higher glycopyrronium concentration; no relationship was observed between efficacy and pharmacokinetic measures. Conclusions These studies indicate limited absorption of GT compared to oral glycopyrrolate and a low risk of anticholinergic adverse events with proper GT administration when following instructions for use (wipe each underarm once with same cloth, wash hands, avoid ocular contact). Supplementary Information The online version contains supplementary material available at 10.1007/s40262-020-00975-y. |
| تدمد: | 1179-1926 0312-5963 0201-6885 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::24502db2cc2d5210f593f4a6cfa276f8Test https://doi.org/10.1007/s40262-020-00975-yTest |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....24502db2cc2d5210f593f4a6cfa276f8 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 11791926 03125963 02016885 |
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