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MHRA rejects POM to P switch for oxybutynin medicine


MHRA rejects POM to P switch for oxybutynin medicine

The MHRA has rejected calls to reclassify the overactive bladder (OAB) medicine Aquiette from prescription only to pharmacy status, saying the evidence shows “that a medical prescription continues to be required” to ensure the drug is used safely.  

The decision, which was announced on Thursday May 11, was made following a review of licence holder Maxwellia’s application for a POM to P switch for the oxybutynin-containing medicine, as well as a public consultation that ran for three weeks in spring 2022.

The MHRA said that after reviewing safety data and taking advice from the Commission on Human Medicines, it reached the decision that an OAB diagnosis “requires medical supervision to ensure that the correct treatment is received, and other health conditions are not overlooked or left untreated”.

Dr Laura Squire of the MHRA that after “taking on board the views of the many patients and healthcare professionals who responded” its position was that Aquiette “still meets the criteria for prescription only status”. 

She added: “We remain committed to improving access to medicines where it is safe to do so and want to reassure patients that Aquiette is safe to use under medical supervision. It is important that patients continue taking their medication and speak to their GP or healthcare professional if they have any concerns about their prescription.”

Manufacturer Maxwellia, which specialises in launching reclassified medicines and in 2021 successfully brought contraceptive pill Lovima to the UK market as a P medicine, said it was “disappointed” by the MHRA’s decision, claiming there is 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”. 

The company said OAB symptoms and fear of incontinence have a “profound effect on quality of life,” adding: “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.”

While the MHRA has yet to publish its report on the 2022 consultation, Maxwellia said there had been an “unprecedented response” and that 78 per cent of all responses “were from patients/members of the public and were supportive of the reclassification”.

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