Sep 25, 2020

VivaGel® BV secures TGA approval for prevention of BV

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 treatment[1] 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.” 

About VivaGel® BV

VivaGel® BV is a novel, non-antibiotic therapy for the treatment of bacterial vaginosis (BV) and relief of symptoms and prevention of recurrent BV. BV is the most common vaginal condition worldwide and twice as common as thrush. One in three women will experience BV and half of these women will have recurrent BV.

BV is a troublesome and often recurrent condition that causes unpleasant vaginal odour and discharge symptoms that have significant social impact for women. BV has also been associated with a range of other serious reproductive health-related medical problems.

VivaGel® BV is available for sale under the brand names Fleurstat BVgel (Australia), Betafem® BV Gel (UK), BETADINE BVTM Gel (Europe) and BETADINETM BV Gel (Asia).

FLEURSTAT BVGEL  (VivaGel® BV)  for the treatment of BV and relief of symptoms

Ask your pharmacist – they must decide if this product is right for you. Always read the label. Follow the directions for use. Do not use for more than 7 days unless a doctor has told you to. See your doctor if symptoms persist after 7 days or recur within 2 weeks, and if you consider you may be at risk of an STI. See a doctor if you are diabetic or pregnant/breastfeeding (or plan to be).

Download full announcement: VivaGel® BV secures TGA approval for prevention of BV (PDF 61kb)

[1] #1 ranking by A$ ex IMS

 This contains certain forward-looking statements.