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AN INTRAVAGINAL RING FOR THE TREATMENT OF GENITAL HERPES

According to the CDC, about 21% of women in the Unites States (i.e. 33 million) are infected with the HSV-2 virus which causes genital herpes. About 20% of those women are symptomatic (6.6 million). Note that asymptomatic women may also suffer from viral shedding and transmit the virus.

Genital herpes may cause painful genital ulcers, which are treated with antivirals such as acyclovir, famciclovir, and valacyclovir. Women that experience more than 2 outbreaks a year usually take these oral antivirals every day. These drugs are also used for the prevention of transmission of genital herpes to uninfected partners.

Auritec Pharmaceuticals has formulated an Acyclovir intravaginal ring which may improve compliance and ease of use in women suffering from genital herpes. This IVR has been tested in vitro and in vivo and has shown sustained-release in a first-in-human clinical trial. It is being further developed for a first-in-human dose-escalation clinical trial.

The global herpes treatment market is forecast to grow to over $4 billion by 2017.

ONE MONTH IN VITRO RELEASE OF ACYCLOVIR INTO WATER


RESULTS OF A FIRST-IN-HUMAN CLINICAL TRIAL ASSESSING SAFETY AND PHARMACOKINETICS OF AN ACYCLOVIR INTRAVAGINAL RING

We performed a first-in-human clinical trial to assess the tolerability and pharmacokinetics in six HIV-negative women with recurrent genital Herpes Simplex Virus (HSV). These women were asked to wear an acyclovir intravaginal ring for 7 days (n = 3) or 14 days (n = 3).

This first study in women of an acyclovir IVR demonstrated that genital tract levels of acyclovir that are similar to oral valacyclovir can be delivered without irritation, inflammation or systemic absorption. 

The study also showed significant reductions in viral titer. 

   

 

 

All six participants reported the ring to be very comfortable.


 

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