Maxwellia addresses criticism of mooted oxybutynin drug reclassification
The manufacturer of a new branded oxybutynin hydrochloride-based drug has responded to concerns raised by healthcare professionals over a proposal to make the medicine available without a prescription.
The proposed reclassification of Aquiette 2.5mg tablets (oxybutynin hydrochloride) from a prescription-only medicine (POM) to a pharmacy (P) medicine was met with some “initial objections” from healthcare professionals on social media last week.
The concerns stem from fears about the anticholinergic burden – the increase in certain side-effects on patients taking more than one medication with anticholinergic substances – associated with the drug’s active ingredient.
However, Aquiette’s manufacturer Maxwellia told C+D yesterday (April 26) that these concerns are based on “inaccurate facts”, saying there are "no safety concerns" associated with the switch.
The Commission on Human Medicines has also suggested that it would be safe for Aquiette 2.5mg tablets to become a P medicine.
Reaction to the proposals
Pharmacist and president of the Primary Care Pharmacy Association Graham Stretch responded to the news on the proposed reclassification by publishing a Twitter thread compiling literature drawing together what he called “mounting evidence” connecting oxybutynin hydrochloride with cognitive decline and the development of dementia.
He feels it is inappropriate for a medicine with this active ingredient to be available over the counter due to its "safety profile", he told C+D. In the short term, oxybutynin hydrochloride can cause side effects including “dry eyes, constipation, confusion, blurred vision [and] increased risk of falls”, Mr Stretch explained.
However, Maxwellia pointed out that it is only the brand Aquiette, and not generic oxybutynin hydrochloride, that is being considered for reclassification, and Aquiette is a new product “specifically designed for sale through pharmacy”.
The anticholinergic burden associated with oxybutynin hydrochloride corresponds “to a much higher dose [than Aquiette contains] used long term in the elderly”, according to Maxwellia.
Aquiette, which will launch first in the UK if the reclassification is approved, will not be made available to women over the age of 65 years, the spokesperson pointed out.
“It is therefore inaccurate to conflate the same level of risk to the Aquiette pharmacy supply model,” a spokesperson told C+D.
Meanwhile, other pharmacists and healthcare workers took to social media to voice their unease over the possible reclassification of Aquiette and called on sector professionals with relevant experience to respond to the consultation.
So disappointed to see this POM➡️P
— Helen Kilminster (Hương Thanh) (@HPILLminster) April 23, 2022
Anyone passionate about women’s health, equity and population health. This is another reason why we need to feed evidence into this consultation. @GrahamStretch articulates the dementia risk. Don’t be fooled by any spin than this empowers women https://t.co/5w8siraVEI pic.twitter.com/3jDFRnouzD
According to Maxwellia’s spokesperson, Aquiette comes in a low 2.5mg dose, is suitable for women aged 18-65 and is indicated for a maximum treatment plan of 12 weeks, in conjunction with bladder training.
“Aquiette is designed for early-stage sufferers of over-active bladder who ordinarily do nothing about their symptoms for up to five years, by which time it is too late, and they will have progressed to needing long-term medication or surgery,” the spokesperson added.
“Oxybutynin is recommended by Nice as first-line treatment following bladder training,” they said.
A step forward for women’s health?
Mr Stretch hopes that, if Aquiette is made available via pharmacies, pharmacists would encourage women suffering with overacive bladder to speak to their doctor before taking Aquiette.
“I can absolutely see the health benefit in widening access for embarrassing conditions via a pharmacy,” he said. “I'm supportive of that happening, but not supportive of this particular proposal.”
Meanwhile, pharmacy minister Maria Caulfield described the MHRA’s consultation on the drug as an “important breakthrough for many women”.
Consultation announced on bladder medication being available without prescription. Important breakthrough for many women on this sensitive issue https://t.co/Cta7iOiwe1
— Maria Caulfield MP (@mariacaulfield) April 23, 2022
