Film for vulvar pain disorders

About

Background Vulvodynia is a chronic pain disorder characterized by vulva burning and soreness in the absence of a skin condition, infection, or external factors. Vestibulodynia is specifically pain felt on touch at the opening of the vagina, otherwise symptoms are absent. Pain is commonly described with insertion of a tampon or vaginal penetration, such as with sexual intercourse. It is estimated that around 8-10% of women of reproductive age are affected by these vulvar pain conditions. The prevalence of these conditions is further demonstrated by prescriptions for vulvar pain being one of the most common medications filled by compounding pharmacies. Women affected by these conditions can have pain that can last for several months or years, with relapse and persistence common. Despite the high prevalence, the exact cause of the disorder remains unknown. Furthermore, the symptoms are associated with other conditions such as depression and anxiety and can have a detrimental effect on daily life and relationships. The standard of care treatment for these conditions is topical anesthetics, the most common being lidocaine, which is applied, sometimes multiple times a day, as an ointment, cream, or gel. Many women also use topical anesthetics on an “as needed basis” such as before sexual intercourse. Treatment with current topical anesthetics have several limitations, including difficulty applying to the affected region due to the anatomical constraints of the vulva, temporary relief, and reports that application is messy and not uniform, resulting in decreased efficacy. This highlights the need for an innovative approach to deliver treatments for vulvar pain conditions, vulvodynia and vestibulodynia, and insertional dyspareunia. Technology Overview Researchers in the Departments of Biomedical Engineering and Obstetrics and Gynecology at the University of North Carolina at Chapel Hill have developed a novel mucoadhesive biocompatible film that is loaded with lidocaine for treating vulvodynia, vestibulodynia, and insertional sexual pain due to other causes. The film is composed of FDA-approved biodegradable polymers that will adhere to mucous membranes and has been specifically engineered for localized delivery of lidocaine. Targeted and localized delivery of lidocaine will provide a more effective treatment than with standard topical formulations and can be tailored to provide immediate (<5 min.) or long-lasting (>120 min.) relief. The film has been designed to be flexible and to meet the anatomical constraints of the vulva treatment area for optimal comfort. Importantly, feedback from patients was gathered to inform aspects of the design and desired anesthetic relief profiles. The film has been tested in vivo and safety studies have demonstrated that the film is well tolerated and non-toxic. In addition to loading the film with lidocaine, other therapeutics could be loaded into the film for treating vulvar skin and vaginal disorders.