Development of the Nestorone®/Ethinyl Estradiol Contraceptive Vaginal Ring (NES/EE CVR); Challenges, Opportunities and Obligations of the Public Sector
ESC Congress Library. Merkatz R. May 28, 2014; 50586; A-171
Dr. Ruth Merkatz
Dr. Ruth Merkatz
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Abstract
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Background:  Bench to bedside development of new contraceptives requires commitment and support from a diverse team of individuals and organizations.   When the public sector develops such products, ongoing support from donors sharing a common goal is essential along with efforts to begin the introductory process early in development.  Identifying potential issues/obstacles associated with introduction, e.g. acceptability, cost and access, are critical components of development consistent with ethical obligations.


Methods:  The process of discovery including compound/delivery system formulation, testing and gaining regulatory approval can span 15-20 years.  Following successful development of several safe and effective long-acting methods requiring placement and removal by trained health care providers, e.g. the Cu IUD, the Population Council recognized the importance of developing long acting methods under a woman's control.  A new CVR containing ethinyl estradiol and Nestorone® (NES), a new non androgenic progestin, was designed to be effective for a full year without requiring refrigeration.  Since NES is a new chemical entity, this CVR required significant amounts of evidence of safety, efficacy, and quality controls for manufacturing.  Additionally, identifying and addressing issues critical for introduction into countries with greatest need has required understanding aspects of acceptability, production costs and distribution. 


Results: Donor support and collaboration was essential for enabling the Council to prepare the regulatory dossier with completion of 55 preclinical and 25 clinical studies. A new drug application with the USA FDA is in preparation for filing in 2014.  Results reveal that safety and efficacy is comparable to recently approved contraceptives; bleeding patterns are favorable.  Acceptability study data collected from > 900 women indicates users are highly satisfied with this method, find it easy to use, are willing to use it in the future and recommend it.  The Council is studying ring acceptability in Kenya, Senegal, Nigeria and India with use of the progesterone vaginal ring, a product already approved in many Latin American countries and indicated for postpartum lactating women to space pregnancies. Simultaneously, work is ongoing with the NES/EE CVR to commercialize and lower production costs with the goal to ensure that purchasers can add this contraceptive to the method mix upon regulatory approvals. 


Conclusions:  Successful contraceptive development requires effective collaboration and management of complex systems.  The mission is urgent and stakes are high. Every component of development must be addressed sufficiently to meet ethical obligations and introduce into the field contraceptives that are safe, effective, acceptable and accessible.


 

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