Vulvodynia is pain in the vulva without a clear identifiable cause that lasts longer than 3 months and is considered a long-lasting, chronic pain condition (Bornstein 2016).
The pain of vulvodynia may be described as itching, burning, or stabbing and is often accompanied by dyspareunia (pain during intercourse) (Bornstein 2016).
Women living with vulvodynia experience excruciating pain during routine activities such as walking, sitting, or even wearing tight-fitting pants. Many are unable to use tampons or engage in sexual activities and intercourse, profoundly affecting their quality of life, intimacy, and relationships. Partners also tend to suffer from anxiety and depression symptoms as well as sexual dysfunction (Myrtveit‐Stensrud 2023).
The two most important factors leading to the profoundly impaired quality of life in vulvodynia patients are the chronic pain in the vulva and impaired sexual function (Bohm-Starke 2024).
Vulvodynia represents a significant unmet medical need, affecting approximately 10% of females, equivalent to at least 18.5 million women over 18 years in the EU alone (Eurostat 2023, Patla 2023). Despite its high prevalence, there are currently no approved medical therapies. The treatments used often carry unacceptable side effects and have poorly documented efficacy.
Women with vulvodynia endure severe physical pain, emotional distress, and societal stigma due to a lack of effective treatment options. Current therapies are mainly off-label, frequently inadequate, and often accompanied by undesirable side effects. As many as 73% of patients try multiple (off-label) therapies in their search for relief (Lamvy 2018). Despite multiple prescribed therapies, many patients (~70%) remain inadequately treated (Patla 2023). They are experiencing high pain scores, averaging 6.7 out of 10 (Schlaeger 2023), and as many as 64% report the worst quality of life score (Patla 2023). This chronic pain condition not only limits daily activities but also severely impairs sexual function, impacting the partners and incurring significant healthcare costs (Lua 2017, Xie 2012).
There is a significant unmet medical need since vulvodynia is a severe chronic pain affecting a large proportion of females. Despite this, no approved pharmacological therapies and no ongoing clinical development activities exist.
Women with vulvodynia are affected by the chronic daily pain, limiting their activities of daily living; at the same time, their sexual life is severely impaired. Pudafensine has the potential to address both issues.
Pudafensine is a small molecule that is easily administered perorally. It is a novel monoamine reuptake inhibitor that is the first to simultaneously address pain and sexual function in women suffering from vulvodynia, the two most bothersome aspects of vulvodynia.
Safety data generated so far (currently more than 450 doses of pudafensine have been administered to approximately 200 healthy subjects and erectile dysfunction patients) indicate that pudafensine is well tolerated.It is expected that its safety will be superior to that of the currently used TCAs and anticonvulsants.