If there is still no medication approved specifically for vulvodynia, what does it mean that one might finally be on the way?
John Connell is Chief Scientific Officer at MAC Clinical Research, one of the UK's longest-established contract research organisations. He has spent over 35 years in clinical research and has been working with Danish biotech Initiator Pharma to develop pudafensine - a drug being investigated specifically for vulvodynia, targeting the dopamine system to interrupt pain signalling. In this episode, John and Mathilde go into the science behind the drug, why it is different from existing treatments, what the early data shows, and what taking part in the clinical trial actually involves.
Pudafensine and the dopamine system: a different approach to vulvodynia pain relief
Most treatments used for vulvodynia - amitriptyline, SNRIs, pregabalin - were not developed for this condition. They are borrowed from other fields, repurposed and applied to chronic vulvar pain they were never designed to address. Pudafensine is different. It is being developed specifically for vulvodynia, working by increasing dopamine levels in the brain to interrupt the way pain signals travel from the vulva to the brain.
Dopamine is most commonly associated with pleasure and reward, but it also plays a significant role in how the brain processes and modulates pain. In preclinical studies, pudafensine showed early promise. In a subsequent study on healthy volunteers using a capsaicin pain model, a single dose reduced allodynia more effectively than pregabalin - and with fewer side effects. That is a meaningful signal for anyone who has cycled through treatments that either did not work or came with a cost that felt too high.
"What we're actually trying to do is to interfere with the pain signaling coming from the periphery of the vulva all the way through to the brain, and this drug will be interfering with that."
The undiagnosed majority: why vulvodynia has been left behind by drug development
Vulvodynia affects millions of women - conservative estimates in Europe put the figure at around 18 million - yet there is still no drug approved specifically for it. Diagnosis can take years. For many women, the condition goes unnamed for so long that the idea of a treatment developed specifically for them can feel almost implausible. The lack of research is not a reflection of how rare or minor the condition is. It is a reflection of how long women's chronic pelvic pain has been deprioritised.
The pharmaceutical industry has been slow to move in this space. Even as pudafensine enters clinical trials, the structural barriers that have kept vulvodynia under-researched remain - funding priorities, diagnostic invisibility, and the tendency to treat pelvic pain as psychological rather than physiological. A positive signal from this trial would not just benefit patients who take the drug. It would establish vulvodynia as a viable target for drug development, opening the door for others to follow.
"In terms of why this is only happening now, it's a mystery to me because it's a massive problem, it's a clear need, and I think the industry perhaps hasn't taken it as seriously as it should up to this point."
The pudafensine clinical trial: what it involves and why it matters
MAC Clinical Research is currently recruiting for the pudafensine clinical trial in the UK. Women aged 18-65 who have experienced vulvar pain for 12 months or more - with or without a formal vulvodynia diagnosis - may be eligible to take part. Clinics are based in Manchester and Blackpool, and participants can receive up to £1,730 plus reasonable travel expenses. In this episode, John walks through every stage of the process: what happens from first contact through to the final visit, and what would or would not disqualify someone from taking part.
This is a pivotal trial - meaning the data collected will directly determine whether pudafensine moves forward as a treatment. That distinction matters. The results of this study will shape what happens next for vulvodynia drug development. For women who have lived with this condition without options, participation is not just about personal access. It is about contributing evidence that could change the treatment landscape for everyone who comes after.
"We want to be able to develop a drug which can be taken at home in the same way that you take an aspirin or a paracetamol and will work for this condition."
How to find out if you are eligible and what to expect
If you are based in the UK, aged 18-65, and have been living with vulvar pain for 12 months or more, you may be eligible for the pudafensine clinical trial. A formal vulvodynia diagnosis is not required to apply. The screening process is the first step, and in this episode John explains in detail what each stage involves - so you can go in knowing exactly what to expect before you decide whether to put yourself forward.
Participants are based at clinics in Manchester and Blackpool and can receive up to £1,730 for their time, plus reasonable travel expenses. For anyone who has spent years without a name for what they are experiencing - let alone a treatment designed for it - this is a real opportunity to be part of something that could matter far beyond their own experience. The sign-up link and full trial details are in the show notes.
