The consultation asks whether Aquiette 2.5mg tablets (oxybutynin hydrochloride) should be reclassified from a prescription-only medicine (POM) to a pharmacy (P) medicine.

Pharmacists and other healthcare professionals, along with women who are currently experiencing symptoms associated with overactive bladder, are being urged to respond to the consultation, which launched today (April 23) and will run until May 6, an MHRA spokesperson told C+D.

“This would be the first time a medicine for the treatment of overactive bladder would be available without prescription,” the MHRA added.

The Commission on Human Medicines has suggested that it is safe for Aquiette 2.5mg tablets to be made available as a P medicine, according to the medicines watchdog.

Oxybutynin hydrochloride-based tablets are used “to treat women with milder symptoms of overactive bladder that are not controlled by bladder training alone”, it explained.

If the switch is approved, pharmacists will receive training and “a checklist” to spot women who can be supplied with this medicine, according to the MHRA.

 

Switch would liberate “hidden subset of women”

 

Aquiette’s manufacturer Maxwellia has not yet launched the product, although the UK will be the product’s first “launch market” if the reclassification is approved, a spokesperson for the pharmaceutical company clarified to C+D.

Should the reclassification be approved, the product will “enable a hidden subset of women to treat overactive bladder without the need to interact with a GP”, Maxwellia CEO and founder Anna Maxwell said in a statement today.

“We see widening access in this way as an important option for people to be able to make their own decisions about their healthcare,” she added.

 

Read more: Podcast – How I’m helping women to take charge of their health

 

Commenting on the launch of the consultation, pharmacy minister and minister for women’s health Maria Caulfield agreed that speaking to a GP about bladder control could “act as a barrier for some women to seek help”.

“The reclassification of Aquiette would enable women to access vital medication without needing a prescription,” Ms Caulfield said.

 

“Comprehensive bladder training programme”

 

Ms Maxwell added that if it goes ahead, the launch of Aquiette will be supported by a “comprehensive bladder training programme”, known as HoldOn, to help women to hold on for longer.

“By combining Aquiette and HoldOn bladder training in a short course of treatment, we aim to help women learn to regain control over their bladders, stop symptom progression, and keep these women out of primary care altogether,” Ms Maxwell said.

 

Read more: Why contraceptive pill POM to P switches present pharmacists with a 'massive opportunity'

 

Pharmacist Michael Holden said: “Suitable advice and treatment for overactive bladder and bladder training is often inaccessible. Pharmacists and their teams are continually looking for new and better ways to support people to care for themselves.”

Women’s health is back at the top of ministers’ agenda. Last year, the government set out its vision for women’s health in England while the MHRA authorised the POM to P medicine switch of two brands of desogestrel contraceptive pills, Lovima and Hana.

Earlier this year, the MHRA also consulted on whether to switch the hormone replacement therapy (HRT) drug Gina 10mcg to a P medicine.