It sure is the VivaGel VB approval!VivaGel® BV secures TGA...

It sure is the VivaGel VB approval!

VivaGel® BV secures TGA approval for prevention of BV
• VivaGel® BV approved claims in Australia have been expanded to also include
prevention of recurrent bacterial vaginosis (BV)
• VivaGel® BV is the only OTC pharmacy product in Australia to be approved for the
treatment of BV and prevention of recurrent BV
• Approximately one in three women experience BV and 40-50% will have a
recurrence within 3-6 months
Melbourne, Australia; 25 September 2020: Starpharma (ASX: SPL, OTCQX: SPHRY)
today announced that the Australia Therapeutic Goods Administration (TGA) has approved
an expansion of the marketing authorisation for VivaGel® BV (Fleurstat BVgel) to now
include the indication of prevention of recurrent bacterial vaginosis. These expanded claims
bring the approved indications for VivaGel® BV (Fleurstat BVgel) in line with those in Europe
and Asia.
BV is the most common vaginal condition worldwide and twice as common as thrush. One in
three women experience BV and it is a highly recurrent condition with 40-50% of sufferers
having a recurrence of BV within 3-6 months. BV is a serious condition that is characterised
by unpleasant vaginal odour and discharge, and caused by an overgrowth of pathogenic
bacteria. BV is associated with a range of serious reproductive health-related medical
problems and results in significant social impacts for women. Recurrent BV has particularly
significant psychosocial impacts on women, including severely affecting self-esteem and sex
life, and avoidance of public settings including their workplace.
The new indication approved by TGA for VivaGel® BV includes prevention of unpleasant
vaginal odour and discharge, and helping to maintain normal vaginal pH and vaginal flora
balance.
VivaGel® BV is an Australian innovation – invented, fully developed and taken through to
commercialisation by Starpharma. VivaGel® BV (Fleurstat BVgel) is the #1 ranked topical BV
treatment1 in Australia, is the only non-antibiotic treatment approved for BV and is available
over-the-counter (OTC) at pharmacies in Australia, without the need for a prescription.
VivaGel® BV is now approved in 40 countries around the world and has also been launched
in Europe, Asia and New Zealand.
Dr Jackie Fairley, Starpharma CEO, commented: “It is great to see the Australian approved
indications for VivaGel® BV now aligned with Europe and Asia. We are also pleased that
Australian women can use the product to prevent, as well as treat, this troublesome and
highly recurrent condition. VivaGel® BV is the only product approved to prevent BV in
Australia.”
Alison Holland, Head of Consumer OTC Business at Aspen Pharmacare Australia,
commented: “Fleurstat BVgel represents a true innovation in the management of bacterial
vaginosis (BV) and empowers women to access BV treatment through their pharmacy. BV
and recurrent BV are both areas of significant unmet need. We are excited to now also be
able to provide an option for the many Australian women that suffer recurrent BV.”