Mucoadhesive film for the treatment of vestibulodynia

Abstract Vestibulodynia (VBD) is a chronic pain condition that occurs when pressure is applied to the vestibule, the area around the opening of the vagina. The condition is characterized by burning, stinging, and stabbing sensations upon touch, as well as tenderness, redness, and dryness of the vestibule. Activities known to commonly cause pain include physical touch, tampon use, intercourse, and exercise (e.g., running); wearing tight clothing is also found to cause pain. VBD is the most common cause of sexual pain and is estimated to affect 11 to 28% of reproductive aged women in the United States. As further evidence of its public health significance, VBD and related vulvar pain conditions cost the US economy over $70 billion annually. There is no single effective treatment for all women with VBD and existing treatments are focused on managing the symptoms of VBD. First-line treatment for both groups include the application of a lidocaine ointment, cream or gel to the vulvar vestibule once or twice daily prior to vulvovaginal manipulation. Topical lidocaine 5% ointment, cream or gel, is difficult to apply due to the content and lack of a directed delivery. The inability to apply a consistent dose of the topical treatment to the vulva and short duration of treatment make this an important focus in delivery system development. Innovative vestibule medication delivery systems are needed to permit efficient, localized therapy that does not interfere with sexual intercourse or the sexual partner. To overcome the challenges associated with the application of topical lidocaine, AnelleO's research team developed two unique flexible, mucoadhesive biodissolvable films to be used as a drug delivery system for VBD. While the vagina has been the site for local delivery of various therapeutic agents, there have been no drug delivery systems designed for application to the vestibule. AnelleO has conducted two clinical studies in parallel with pre-clinical work. The team completed a survey of 21 women with VBD to evaluate barriers to available treatment, personal satisfaction with current treatment, and preferences for future treatment. Building on these data, the following aims are proposed: 1) conduct in-depth assessment of patient preferences and attributes about the vulvar film physical characteristics of texture/thickness/flexibility, size/shape, appearance, application, and feel/comfort, 2) implement and optimize the final product design based on patient preferences input (Aim 1) and finalize quality control tolerances of the 5% lidocaine film, 3) schedule a pre-IND meeting with the FDA and conduct IND-enabling studies for 5% lidocaine film, and 4) draft and submit an IND application to the FDA. This work will assist AnelleO in bringing longer-lasting comfort to women with VBD, addressing a highly unmet need in the area of women's sexual health.