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.

抽象的 前庭（VBD）是一种慢性疼痛状况，当施加压力到前庭时，该区域施加压力 在阴道开口周围。这种情况的特征是燃烧，刺痛和刺伤感觉 触摸，以及前庭的压痛，发红和干燥。通常已知的活动 疼痛包括身体触摸，卫生棉条使用，性交和运动（例如，跑步）；穿紧身衣服也是 发现会引起疼痛。 VBD是性痛苦的最常见原因，估计会影响11％至28％ 美国生殖老年妇女。作为其公共卫生意义的进一步证据，VBD和 相关的外阴痛条件每年使美国经济损失超过700亿美元。没有一个有效的 所有患有VBD和现有治疗方法的妇女的治疗都集中在管理VBD的症状上。 两组的一线治疗包括将利多卡因软膏，奶油或凝胶应用于外阴 每天一次或两次前庭操作。局部利多卡因5％软膏，奶油或凝胶是 由于内容和缺乏定向交付而难以应用。无法施加一致的剂量 对外阴和短期治疗时间的局部治疗使这成为交付系统的重要重点 发展。需要创新的前庭药物输送系统以允许有效的局部治疗 这不会干扰性交或性伴侣。克服相关的挑战 随着局部利多卡因的应用，Anelleo的研究团队开发了两个独特的柔性，粘附性 可以用作VBD的药物输送系统的可生物溶剂胶片。而阴道一直是当地的网站 交付各种治疗剂，没有旨在应用于该药物的药物输送系统 前厅。 Anelleo与临床前的工作并行进行了两项临床研究。团队完成了 对21名具有VBD女性的调查，以评估可用治疗的障碍，个人满意度 治疗和未来治疗的偏好。在这些数据的基础上，提出了以下目的：1） 深入评估患者偏好和有关外阴膜物理特征的属性 质地/厚度/灵活性，大小/形状，外观，应用和感觉/舒适性，2）实施和优化 基于患者偏好输入（AIM 1）的最终产品设计并确定质量控制公差 5％利多卡因膜，3）安排与FDA的预先开会，并进行5％的指定研究 利多卡因电影和4）草稿并向FDA提交IND申请。这项工作将有助于Anelleo带来 为患有VBD的女性而言，持久的舒适性更长 健康。