Initiator Pharma completes dosing of the last patient in Phase 2a study of pudafensine in vulvodynia
Initiator Pharma completes dosing of the last patient in Phase 2a study of pudafensine in vulvodynia
Initiator Pharma A/S, a clinical-stage biotech company, today announced final dosing of the last planned patient in its Phase 2a clinical proof-of-concept study evaluating pudafensine in women suffering from the genital pain condition vulvodynia.
The randomized, placebo-controlled Phase 2a study including 24 women diagnosed with vulvodynia has now completed recruitment and dosing of patients. Each participant received single oral doses of pudafensine and a placebo across different treatment periods, separated by washout intervals in a four-way crossover design. The study evaluates the pain-relieving effects and the safety of pudafensine, and release of topline data is expected during February 2027.
“We have, in collaboration with MAC Clinical Research completed the recruitment and dosing in the clinical vulvodynia study. This milestone marks an important step forward in our mission to develop a new treatment for the patients living with this under-recognized and debilitating pain condition,” said Claus Olesen, CEO of Initiator Pharma. “Pudafensine has already demonstrated strong clinical potential and this study is designed to deliver the first proof-of-concept data in vulvodynia – a chronic pain condition with significant unmet medical need and no medications currently specifically approved for the condition.”