In Interviews

Follow this topic

Bookmark

Record learning outcomes

POM-to-P specialist manufacturer Maxwellia has achieved what it describes as a record turnaround time for bringing its latest product switch to market. P3pharmacy caught up with chief executive Anna Maxwell

What are your criteria when targeting a molecule for a potential switch? 

It all starts with consumer need. Through Maxwellia’s unique dynamic switch process, we identify a signifi cant unmet need or public health concern where access to eff ective medicines is limited, and assess how we can unlock that pathway for people. We have screened many prescription drugs for their switchability potential, taking into account their clinical viability, regulatory feasibility, and commercial potential. 

Our goal is always the same: to widen access to trusted medicines to broaden the role of the pharmacist and empower people to manage their own health. Switching Naprosyn was an obvious choice, I have had it in my sights since the early 1990s. The active ingredient, naproxen, has been used globally for four decades; its side effect profile, interactions and contraindications are well understood; it is already available over the counter in many countries. 

Naproxen is a well-established, powerful anti-inflammatory with more than seven million prescriptions written annually in England alone. Maxwellia successfully launched Ultravana, a naproxen medicine for period pain in 2024 as we knew many women didn’t always find other options effective enough. We recognised a similar unmet need in musculoskeletal pain, where patients regularly report wanting stronger relief without prescription. In 2024, pain was identified by the Medicines and Healthcare products Regulatory Agency (MHRA) as a priority category for reclassification. 

What was the turnaround time between applying for the Naprosyn reclassification and the product coming to market? 

We work closely with the MHRA and PAGB to improve the quality of switch applications to achieve a ‘right fi rst time’ standard. To date, Maxwellia has delivered five new brands to the over-the-counter (OTC) market in contraception, period care and now pain relief and this has been our fastest submission to launch timeline yet. 

I believe that the work undertaken by the Reclassification Alliance has enabled this switch to be fast-tracked, enabling us to create a new segment in the pain relief channel, which will drive incremental growth for pharmacy. 

The Naprosyn Pain Relief switch was made possible due to a strategic partnership with global pharmaceutical company Pharmanovia, which enabled the originator brand (Naprosyn) and its heritage prescription molecule to be sold over the counter in pharmacies. 

The MHRA granted a marketing authorisation for Naprosyn Pain Relief as a pharmacy medicine for the relief of common acute musculoskeletal conditions in May 2025 and we have brought it to market in 20 weeks. 

In February the MHRA published a list of conditions and indications that are ‘suitable for reclassification’. Has the drugs industry stepped up reclassification applications in response? 

The priority list sent a clear signal to industry to accelerate reclassifi cation activity. But it’s early days. The list is not a guarantee of approval, and high-quality applications will be essential to achieve switch success. 

Do some conditions on the MHRA list lend themselves to P-medicine product launches more than others? We will need to wait and see if reclassifi cation proves more challenging for some conditions on the MHRA list, but Maxwellia welcomes the renewed focus on medicine reclassifcation. Reclassification is both a healthcare and economic priority. 

Each year, millions of GP appointments and A&E visits are for self-treatable conditions that could be managed with OTC medicines. Since 2013, we’ve focused exclusively on transforming trusted prescription medicines into accessible, consumer friendly OTC brands. 

Are switches good for community pharmacies and their patients? And are policymakers receptive to the arguments around cost-saving? 

Absolutely. For community pharmacies, they represent a new source of growth. With around 90 per cent of pharmacy income still reliant on NHS funding, switched OTC medicines help reduce that dependency, boosting margins and freeing up time otherwise tied up in prescriptions and administration. 

Pharmacists can provide fast, eff ective treatment for acute muscle and joint pain right at the counter, improving access for patients while strengthening their bottom line. Policymakers also understand the benefits. The MHRA and Department of Health and Social Care have both recognised that enabling self-care for common conditions can deliver signifi cant savings. 

Naprosyn Pain Relief is a perfect example of how reclassifi cation can relieve system pressure while empowering patients and supporting community pharmacy. 

What are some key ambitions for Maxwellia in the next 1-3 years? 

Our focus is on accelerating our switch pipeline to bring more trusted prescription medicines to market as accessible brands. We’ve proven through Evana and Naprosyn Pain Relief that reclassifi cation works, empowering people and easing pressure on the NHS.