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New Medicines

VivaGelBacterial vaginosis - prevention of recurrence

Information

VivaGel
New formulation
StarPharma
StarPharma

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Pre-registration (Filed)
Jun 18Starpharma and Mundipharma entered a licence agreement for the sales and marketing rights to astodrimer for 43 countries in Europe [10].
Dec 17Starpharma is seeking partners for out-licensing commercial rights for VivaGel® BV across different regions [9].
Nov 17Filed in US [9].
Jan 17US FDA grants Qualified Infectious Disease Product (QIDP) designation and Fast Track designation to astodrimer for treatment of bacterial vaginosis [9].
May 16Not listed on EMA or Mutual Recognition websites - could be marketed as a Medical Device.
Sep 15Starpharma announce marketing approval granted in EU [8].
Nov 12Company will not file in the US in 2013 as planned because two PIII studies did not meet primary endpoint [5].
Jan 12Starpharma has received agreement on the design of its two PIII studies under the FDA’s Special Protocol Assessment (SPA) scheme. Agreement with the EMA has also been reached. The company plans to start its PIII programme early in 2012 with completion expected before year end [2].

Category

SPL 7013 is a branched macromolecule, one of a series of second-generation dendrimers
Prevalence has been reported as 5% in a group of asymptomatic college students, 12% in pregnant women attending an ante-natal clinic and 30% in women undergoing termination of pregnancy. [3]
Bacterial vaginosis - prevention of recurrence
Topical

Trial or other data

Mar 15NCT02237950 and NCT02236156 are two PIII double-blind RCTs to determine the efficacy and safety of SPL7013 gel to prevent the recurrence of bacterial vaginosis. Each trial plans to enroll 620 subjects with both a history of recurrent BV and a current episode of BV, all of who will receive a 7 day course of oral metronidazole and either 1% SPL7013 gel or placebo gel on alternate days at bed-time for 16 consecutive weeks. The primary endpoin is recurrence of BV. The studies started in Sep 14 and are due to complete Dec 15 [7].
Mar 14No further update
Apr 13Positive results of PII study of VivaGel® for the prevention of recurrent bacterial vaginosis (R-BV) reported a reduced overall risk of R-BV during the study in patients using 1% VivaGel® and time to first recurrence was delayed compared with placebo. In the study, 205 women were randomised to VivaGel® containing either 1% or 3% SPL7013, or placebo (every second day for 16 weeks) following a course of conventional BV treatment (metronidazole) [6].
Nov 12Results of two PIII studies reported. The studies did not meet the primary endpoint of clinical cure 2-3 weeks after the cessation of treatment (Test of Cure, TOC visit). Each study (SPL7013-015 and SPL7013-016) enrolled ~ 250 women; at TOC, the clinical cure rates for VivaGel and placebo were 27% vs 21%, and 28% vs 28% in each study, respectively. 50% and 57% women, respectively, achieved clinical cure with VivaGel vs 17% and 21% with placebo (p
Apr 12Two P3 studies, NCT01577537 and NCT01577238, started. The primary objective is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel, 5g PV at bedtime for 7 days, for the treatment of bacterial vaginosis in females >12 yrs of age. Both due to complete Dec 2012. Estimated enrolment 220 per study. [4]
Jan 12Starpharma has a licence agreement with Ansell Limited to develop a VivaGel®-coated condom [2]
Oct 11PIII clinical trial programme agreed with US FDA, with approx. 220 participants. Primary endpoint will be clinical cure, assessed by resolution of symptoms. Comparator will be placebo gel. [1]
Oct 11Primary endpoint of P2 study showed significant efficacy for treatment of bacterial vaginosis. Treatment with 1% VivaGel® once daily for seven days resulted in 74% of patients achieving Clinical Cure of BV 2 to 5 days after completion of therapy compared with just 22% in the placebo group (P=0.0002). Patient acceptability of the product was very high with 83% of patients using 1% VivaGel® being extremely satisfied, very satisfied or satisfied with the product when taking all aspects of the treatment into account. [1]