China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) has completed patient enrollment in a Phase III clinical study for Intrarosa (prasterone). The drug is a vaginal non-estrogen treatment for moderate to severe painful sex due to menopause.
Phase III Trial Design
The multi-center, randomized Phase III trial is designed to compare the safety and efficacy of Intrarosa with a placebo in the Chinese population. The trial will enroll 418 patients across 28 centers. The primary endpoint is changes in sexual intercourse pain severity scores on the 1st and 85th days. Topline results are expected in or before March 2023.
Intrarosa Profile and Regulatory Approvals
Intrarosa, licensed from Canada-based Endoceutics Inc., is the only approved estrogen-free steroid for daily local use to treat vulvar and vaginal atrophy (VVA) due to menopause. The drug contains prasterone, an inactive endogenous steroid that can be converted into androgen and estrogen, which helps repair vaginal fibrous tissue. Intrarosa has been approved by the US FDA and European Medicines Agency (EMA) and was launched in the US, Europe, and Canada in November 2016, January 2018, and November 2019, respectively.
Future Outlook
With the completion of patient enrollment, Zhaoke Ophthalmology is poised to advance the clinical development of Intrarosa, aiming to provide a new treatment option for women experiencing menopause-related symptoms in China.-Fineline Info & Tech
