A post in this blog during National Women’s Health Week 2016 discussed six areas of significant unmet medical needs in women’s health. This post for National Women’s Health Week 2018 provides an update on the status of product development in addressing three of those areas of unmet need.
- Increased availability of noninvasive diagnostics for health conditions like endometriosis
- Improved therapeutics for osteoporosis
- More effective therapeutics for female sexual dysfunction
In addition, this post will provide information on the clinical development of new treatments for heavy menstrual bleeding, a condition that accounts for approximately one-third of outpatient visits to gynecologists.
Increased Availability of Noninvasive Diagnostics in Women’s Health
It is encouraging to see growing activity in the development of noninvasive diagnostics for women’s health conditions. One positive sign is a solicitation, “Non-invasive Diagnostics to Improve Gynecologic Health,” from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a unit of the National Institutes of Health. Another positive sign is commercial activity in areas including a saliva-based test for endometriosis.
Therapeutics for Osteoporosis that Promote Patient Adherence
There are effective osteoporosis therapeutics but patient nonadherence is a substantial problem. Formulations for administration weekly, monthly and quarterly have addressed the nonadherence problem to some degree. Otherwise, current development activity appears to be focused not on novel treatments but on improving the efficacy or tolerability of existing agents or developing biosimilars. Overall, the development landscape for osteoporosis products is disappointing. The reason is the apparent failure of what was once a promising next-generation of osteoporosis therapeutics based on cathepsin K inhibitors. Merck pulled the plug on its cathepsin K inhibitor odanacatib in September 2016, just four months after National Women’s Health Week 2016, because of concerns about stroke risk. Other developers of cathepsin K inhibitors did likewise. Where there had been six product candidates in this category from five companies, suddenly there were none. The next wave of novel osteoporosis therapeutics is yet to come.
More Effective Therapeutics for Female Sexual Dysfunction
Flibanserin has experienced limited market success following its approval for treatment of Hypoactive Sexual Desire Disorder and there have been no additional approvals of treatments for Female Sexual Dysfunction, a term that encompasses Female Sexual Interest/Arousal Disorder (FSIAD), Female Sexual Arousal Disorder (FSAD), Female Orgasmic Disorder and Genito-Pelvic Pain/Penetration Disorder. Nevertheless, sponsors are active in development of novel therapeutics for different forms of FSD. Health Decisions is aware of commercial development programs for novel treatments for FSIAD, FSAD and dyspareunia. For women experiencing FSD, there is hope that more effective treatments may be on the way.
Clinical Development of Improved Treatments for Heavy Menstrual Bleeding
Health Decisions’ Chief Medical Officer Andrea S. Lukes, MD, MHSc, FACOG, has strong interest and deep expertise in treatments for heavy menstrual bleeding. To observe National Women’s Health Week and assist developers of new HMB treatments, Dr. Lukes will provide a webinar that offers medical background on HMB as well as both PI and patient perspectives on clinical trials of HMB treatments. Dr. Lukes will discuss topics including strategies for patient recruitment, prescreening, screening and retention. In addition, Dr. Lukes will introduce a patient who participated in an HMB trial to share her first-hand experiences. Registration for the webinar is open. “Heavy Menstrual Bleeding: Medical Background and PI and Patient Perspectives on Clinical Trials,” will take place Tuesday, May 15, 2018, at 1 pm EDT / 10 am PDT.