Glycopyrronium (1) – Axhidrox®
Severe primary axillary hyperhidrosis
Characteristics
| Start date | 01.08.2022 – Marketing authorisation: 01.06.2022 |
|---|---|
| Resolution | 19.01.2023 |
| INN | Glycopyrronium |
| Brand name | Axhidrox® |
| Pharm. company | Dr. August Wolff GmbH & Co. KG Arzneimittel |
| G-BA Procedure ID | D-850 |
| ATC code | D11AA01 Antihidrotics (D11AA) |
| ICD-10 codes (AIS) | R61.0, R61.9 |
| Alpha-ID codes (AIS) | I32318Hyperhidrosis, I9414Circumscribed hyperhidrosis |
| DDD | 8.8 mg T |
| Therapeutic area | Other diseases Hyperhidrosis |
| Reason for procedure | Initial assessment – New data exclusivity (known INN) |
| Therapeutic indication of the resolution |
|---|
|
Axhidrox is used for the topical treatment of severe primary axillary hyperhidrosis in adults |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with severe primary axillary hyperhidrosis | A prescription containing aluminium chloride (at least 15 %) or tap water iontophoresis |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (Hyp1-18/2016) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- The Hyp1-18/2016 study was a randomised, double-blind, placebo-controlled trial involving adults aged between 18 and 65 years with severe primary axillary hyperhidrosis.
- The Hyp-02/2015 study is a randomised, double-blind, placebo-controlled study in which glycopyrronium was administered at three different doses (0.5%, 1% and 2%).
Adults with severe primary axillary hyperhidrosis
- The additional benefit is not proven.
- In the overall review, no data suitable for benefit assessment are available. The additional benefit of glycopyrronium compared with the appropriate comparator therapy is therefore not proven for the indication ‘for the topical treatment of adults with severe primary axillary hyperhidrosis’.
- Overall assessment
- Overall, there are no data available that are suitable for a benefit assessment. The additional benefit of glycopyrronium compared with the appropriate comparator therapy is therefore not proven for the indication ‘for the topical treatment of adults with severe primary axillary hyperhidrosis’.
- In the overall assessment, the additional benefit of glycopyrronium compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Glycopyrronium (1) | Axhidrox® | Dr. August Wolff GmbH & Co. KG Arzneimittel | Severe primary axillary hyperhidrosis | 73,000–704,000 | 100% additional benefit not proven |
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