NICE has recommended glycopyrronium bromide cream as an option for adults with severe primary axillary hyperhidrosis whose symptoms remain inadequately controlled with existing treatments.

NHS recommendation expands treatment options

The final NICE guidance recommends glycopyrronium bromide cream for adults with severe primary axillary hyperhidrosis when lifestyle advice, topical aluminium-based antiperspirants and oral antimuscarinic medicines have not adequately controlled symptoms, are contraindicated or are not tolerated.

Primary axillary hyperhidrosis causes excessive sweating of the underarms beyond what is needed for normal temperature regulation. The condition can affect daily activities, social interactions and quality of life, but is often under-recognised and under-diagnosed.

NICE estimates that around 75,000 people in England may be eligible for treatment with glycopyrronium bromide cream.

The treatment is applied directly to the skin and can be self-administered at home, potentially allowing it to be managed largely in primary care.

Glycopyrronium is an anticholinergic medicine that blocks chemical signalling involved in activating sweat production.

The recommendation makes glycopyrronium bromide cream available as an NHS treatment option for eligible adults with severe primary axillary hyperhidrosis after other treatments have failed or cannot be used.

Phase 3 studies support recommendation

NICE’s recommendation is supported by clinical evidence from Phase 3 studies evaluating the cream in adults with primary axillary hyperhidrosis.

In a four-week Phase 3a study, the reduction in sweat production from baseline to Day 29 was significantly greater among patients receiving 1% glycopyrronium bromide cream than those receiving placebo.

The study included 87 patients receiving glycopyrronium bromide cream and 84 receiving placebo. The proportion of patients achieving at least a 50% reduction in sweat production was approximately 1.7 times higher with treatment, while the proportion achieving at least a 90% reduction was approximately 2.4 times higher.

A secondary analysis also found improvements in quality of life across three patient-reported outcome measures.

A subsequent 72-week Phase 3b extension study included 357 patients. After 12 weeks of treatment, median total sweat production had fallen by 65.6% from baseline.

At week 12, 54.1% of patients achieved at least a 50% reduction in sweat production, while 36% achieved at least a 75% reduction and 22% achieved at least a 90% reduction.

Quality of life remained significantly improved compared with baseline throughout the study period.

Treatment provides a topical option

The longer-term study also found that the reduction in sweating was maintained while the median frequency of application decreased from seven applications per week at week four to three applications per week at week 72.

The most commonly reported adverse events included application-site reactions, dry mouth and dry eye. Other reported adverse events included headache, dry skin, nasal dryness, constipation and blurred vision.

The manufacturer said dry mouth tended to decrease with longer treatment, while there was no evidence that adverse events increased in severity with longer treatment.

Richard Baderin, managing director of axunio UK, said: “Hyperhidrosis can have a profound impact on many aspects of daily life, yet treatment options have historically been limited. The NICE recommendation for GPB cream represents an important milestone for adults living with severe primary axillary hyperhidrosis and provides access to the UK’s only licensed topical anticholinergic treatment for this condition.”

The NICE recommendation applies to adults with severe primary axillary hyperhidrosis who meet the specified treatment criteria.

For patients whose excessive underarm sweating has not been adequately controlled by lifestyle measures and existing medicines, the decision provides an additional treatment option within the NHS in England.