The Medicines and Healthcare products Regulatory Agency (MHRA) last week (May 11) announced that Aquiette 2.5 mg tablets for symptoms of overactive bladder “will remain a prescription-only medicine”.

It decided to maintain the prescription-only medicine (POM) status of the drug “following a public consultation and the review of a reclassification application from the manufacturer”.

Read more: MHRA rejects POM to P reclassification of oxybutynin drug after ‘robust’ review

But Aquiette’s manufacturer Maxwellia told C+D yesterday (May 17) that it is “currently reviewing the MHRA decision and considering its next step”.

However, it is too early to say anything more about what actions it could take, it said.

Aquiette contains the active ingredient oxybutynin and is used to treat long-term symptoms of overactive bladder (OAB), such as the urgent need to urinate and frequent urination without pain, in women aged between 18 and 65. 

 

Manufacturer “disappointed”

 

Maxwellia is “disappointed that the MHRA proposes to maintain a prescription-only status” for Aquiette 2.5mg tablets “despite an urgent need for improved access to treatment for OAB and overwhelming support from women and members of the public”, a spokesperson said. 

“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,” they continued.

The spokesperson claimed that advertising for continence products such as pants and pads “normalises incontinence and is leading women to believe it is a normal part of aging”.

This means that those affected do not realise that other options, such as bladder training or pharmacological treatment, are available and do not seek help for their condition, they said.

Read more: Maxwellia addresses criticism of mooted oxybutynin drug reclassification

The MHRA said that the public consultation on reclassifying the product received an “overwhelming number of responses” about the “benefits and risks of reclassification”.

It also “flagged concerns” from patients, healthcare professionals and “key” stakeholders such as the Royal Pharmaceutical Society (RPS) and the British Medical Association (BMA), it added.

The consultation gathered patient responses that “provided valuable insights and feedback on the impact of patient access,” according to the MHRA.

 

“Safe use”

 

In making its decision, the MHRA also “conducted a thorough review of safety data” and sought “independent advice” from the Commission on Human Medicines (CHM), it said.

“The review process considered all available evidence, including the responses received in the consultation, on the safety of Aquiette,” it added.

Read more: MHRA mulls making oxybutynin hydrochloride medicine available without script

The MHRA said that its assessment of the reclassification application “concluded that a medical prescription continues to be required to ensure the safe use of Aquiette”.

“An OAB diagnosis requires medical supervision to ensure that the correct treatment is received and other health conditions are not overlooked or left untreated,” it added.

The decision to maintain Aquiette’s POM status “ensures that the medication is used safely and appropriately under medical supervision,” it said.

 

“Robust review”

 

MHRA chief healthcare quality and access officer Dr Laura Squire said that the regulator “decided to refuse the reclassification” of the tablets “after taking on board the views of the many patients and healthcare professionals who responded”.

“Independent advice from the Commission on Human Medicines (CHM), our own robust review of the available safety data and the overwhelming responses from our consultation were invaluable in helping us understand that Aquiette still meets the criteria for prescription-only status,” she added.

The MHRA remains “committed to improving access to medicines where it is safe to do so”, Dr Squire said, adding that Aquiette is “safe to use under medical supervision”. 

 

Maxwellia: “No safety concerns”

 

The MHRA launched its consultation on the reclassification of Aquiette 2.5 mg tablets from a POM to a pharmacy (P) medicine in April last year.

It said at the time that the CHM had suggested that it is safe for the tablets to be made available as a P medicine.

Maxwellia had not yet launched the product, although the UK was to be the product’s first “launch market” if the reclassification were approved, a spokesperson for the pharmaceutical company clarified to C+D at the time.

But the proposed reclassification was met with some “initial objections” from healthcare professionals on social media in the same month the consultation was launched.

The concerns stemmed 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 said at the time that these concerns were based on “inaccurate facts”, saying there are "no safety concerns" associated with the switch.

It also said that if the reclassification were approved, the product will “enable a hidden subset of women to treat overactive bladder without the need to interact with a GP”.

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