Mucoadhesive film for the treatment of vestibulodynia

治疗前庭痛的粘膜粘附膜

• 批准号: 10699463
• 负责人: Soumya Rahima Benhabbour
• 金额: $ 89.19万
• 依托单位: ANELLEO, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10699463
• 关键词: Address; Adhesions; Affect; Anatomy; Anesthetics; Appearance; Area; Body Regions; Characteristics; Chronic; Client satisfaction; Clinical Research; Clothing; Coitus; Cream; Data; Dimensions; Dose; Drug Delivery Systems; Dryness; Esthesia; Exercise; Extravasation; Film; Future; Gel; Immunologics; In Vitro; Inflammatory Response; Interpersonal Relations; Length; Lidocaine; Life; Local Anesthetics; Local Therapy; Ointments; Operative Surgical Procedures; Pain; Patient Preferences; Penetration; Peripheral; Personal Satisfaction; Pharmaceutical Preparations; Positioning Attribute; Process; Public Health; Quality Control; Redness; Reporting; Research; Running; Schedule; Self Administration; Sexual Health; Sexual Partners; Shapes; Site; Sting Injury; Surface; Surgical Management; Surveys; System; Systems Development; Tampons; Texture; Therapeutic Agents; Thick; Thinness; Time; Tissues; Topical application; Touch sensation; United States; Vagina; Vestibular Nerve; Vestibule; Vestibulodynia; Vulva; Width; Woman; Work; aged; chronic painful condition; compliance behavior; cost; design; effective therapy; efficacious treatment; flexibility; hydroxyethylcellulose; innovation; labia; novel; pain sensitivity; pre-Investigational New Drug meeting; pre-clinical; preference; pressure; psychologic; reduce symptoms; reproductive; surgical risk; symptom management; treatment duration; vulvar pain

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.

摘要 前庭痛（VBD）是一种慢性疼痛状态，当压力施加到前庭时， 在阴道口周围这种情况的特点是燃烧，刺痛，刺伤的感觉 触摸时，以及压痛，发红，前庭干燥。已知的活动通常会导致 疼痛包括身体接触、性交、性交和运动（例如，跑步）;穿紧身衣也是 发现引起疼痛。VBD是性疼痛的最常见原因，估计影响11%至28%的女性。 美国的育龄妇女。作为其公共卫生意义的进一步证据，VBD和 相关的外阴疼痛病症每年花费美国经济超过700亿美元。没有一个有效的 所有患有VBD的女性的治疗和现有的治疗集中在控制VBD的症状。 两组患者的一线治疗包括在外阴涂抹利多卡因软膏、乳膏或凝胶 前庭，每日一次或两次，然后进行外阴阴道操作。局部使用5%利多卡因软膏、乳膏或凝胶， 由于内容和缺乏定向传递而难以应用。无法使用一致剂量的 对外阴的局部治疗和短的治疗持续时间使其成为递送系统的重要焦点 发展需要创新的前庭给药系统来实现有效的局部治疗 不妨碍性交或性伴侣。为了克服相关的挑战， 通过局部应用利多卡因，AnelleO的研究小组开发了两种独特的柔性粘膜粘附剂， 生物可溶解膜用作VBD的药物递送系统。虽然阴道一直是局部 尽管药物递送系统用于递送各种治疗剂，但还没有设计用于应用于 前厅AnelleO在临床前工作的同时进行了两项临床研究。该团队完成了一项 对21名VBD女性进行调查，评估可用治疗的障碍、个人对当前治疗的满意度 治疗和未来治疗的偏好。根据这些数据，提出了以下目标：1） 深入评估患者对外阴胶片物理特征的偏好和属性 质地/厚度/柔韧性、尺寸/形状、外观、应用和手感/舒适度，2）实施和优化 最终产品设计基于患者偏好输入（目标1），并最终确定 5%利多卡因薄膜，3）安排与FDA的IND前会议，并进行5%利多卡因薄膜的IND使能研究 利多卡因薄膜，以及4）起草并向FDA提交IND申请。这项工作将有助于AnelleO带来 为患有VBD的女性提供更持久的安慰，解决女性性行为领域高度未满足的需求， 健康