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MHRA decision on Aquiette reclassification

Alderley Park, UK – 12 May 2023

Despite an urgent need for improved access to treatment for overactive bladder (OAB) and overwhelming support from women/members of the public*, Maxwellia is disappointed that the MHRA proposes to maintain a prescription-only status for low dose oxybutynin hydrochloride 2.5mg tablets, Aquiette®.

There is currently a large unmet need among an identified, yet hidden population of otherwise well women who are early-stage sufferers of OAB and who do not realise they have a treatable condition. Many delay consulting a doctor for years, even when OAB progresses and urinary incontinence becomes a frequent occurrence. Early in the evolution of OAB, the major symptoms of urgency and frequency, and fear of incontinence have a profound effect on quality of life. Advertising on television for continence products such as pants and pads normalises incontinence and is leading women to believe it is a normal part of aging. They remain unaware that bladder training and pharmacological treatment are available. Consequently, women are currently not seeking help.


Maxwellia is currently reviewing the MHRA decision and considering its next step.

(*There was an unprecedented response to the public consultation in 2022. 78% of the total responses were from

patients/members of the public and were supportive of the reclassification)


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