Pudafensine on the Horizon: What a New Drug Trial Could Mean for Vulvodynia Sufferers
Here at the London Pain Clinic, our world-class Vulva Doctors are well known for providing accurate vulva pain diagnoses and multifaceted Holistic Personalised Treatment Plans. We have helped countless women, many of whom have had to suffer in silence for years on end. To that end, we would like to inform readers of a possible medical breakthrough. -Initiator Pharma is now beginning Phase 2a clinical trials for an innovative pharmaceutical treatment (pudafensine) to stop neurogenic vulvar pain.
So What is Pudafensine Exactly?
Pudafensine is classed as a monoamine-reuptake inhibitor with a preference for dopamine transporters. It has been shown to ameliorate erectile function in both male rats and patients. – And now, researchers have speculated that it could encourage sexual behaviour, and thus rev up blood flow in female rat genitalia.
The Low-Down on Vulvodynia
A huge amount of research indicates that Vulvodynia is a common female genitalia disorder which causes relentless pain in the vulva. Yet despite an estimated 18% of females in the UK being affected by it at some time in their lives, it is still nonetheless largely under-researched and under-diagnosed. – The latter scenario is particularly applicable to GPs (who have not undergone the necessary additional years of training and clinical expertise of that of a Pain Doctor).
Did You Know?
Statistics reveal that: “on average, people with Vulvodynia see three or more [general] doctors before receiving a diagnosis, and that often a diagnosis is never reached. And while Vulvodynia is considered and treated as “pain during intercourse”, we also know that women with Vulvodynia live with vulvar pain daily, even without intercourse. It is persistent pain in its own right and not only sexual pain” [1], and that is why our Fibro Consultants take a holistic approach to ameliorating this life impacting condition. So this means that patients can be offered a combination of contemporary medicine, as well the the latest leading-edge therapies and injectables (including pain blockers and Botox).
Pudafensine Study Details
The study will be carried out in conjunction with MAC Clinical Research in Britain. Recently, the “Initiator Pharma entered an agreement with MAC Clinical Research (MAC), in which MAC will take on the cost up to GBP 2.5 million, for conducting a clinical Phase 2a proof-of-concept study evaluating pudafensine in patients suffering from vulvodynia” [2]. It is anticipated that the study will begin enrolling patients prior to the end of 2025, and that the study will conclude by the end of 2026 [2].
What Are the Signs of Vulvodynia?
As our Vulva Specialists regularly explain: the key indication of vulvodynia is inexplicable persistent pain or discomfort in the vulva region. The pain can come and go, or remain constant. Specific pain sensations that you should report to your Pain Doctor on your first online or in-person consultation, comprise:
- Burning
- Throbbing
- Stabbing
- Rawness/soreness
- Aching
- Irritation
- Itching or
- Swelling
When Are These Sensations Likely to Happen?
- After passing water
- Whilst exercising
- When inserting a tampon
- Having sex
- When resting or sitting down
Things to Be Mindful Of
Having vulvodynia means:
- No change in appearance (in the majority of women, the the vulva looks normal)
- Timescale (the vulva pain should be present for 12 weeks-plus
- Emotional fallout (long-term pain can result in insomnia, depression, feeling anxious, and issues with intimate relationships)
References
[1]. NIHR Maudsley Biomedical Research Centre (2021).”The silent and widely impacting cost of Vulvodynia: lessons learned and future recommendations.”
[1]. MarketScreener (2025). “Initiator Pharma Applies to Initiate Phase 2a Study in Vulvodynia.”