1 September 2024
Starpharma commences pivotal phase 3 VivaGel trials for bacterial vaginosis treatment
Melbourne Australia: Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced the commencement of two concurrent pivotal phase 3 clinical trials of VivaGel® for the treatment of bacterial vaginosis (BV), following receipt of ethics approval.
Key Points:
- Two pivotal phase 3 trials launched for the treatment of bacterial vaginosis (BV)
- Special Protocol Assessment (SPA) already received from the FDA which confirms the design of the planned studies is acceptable to support a New Drug Application (NDA) and marketing approval of VivaGel®
- Trials to be completed in 2012
- Preparation of NDA submission and out-licensing discussions to follow
Download ASX Announcement ( pdf file, 193kb)