JNP-0201 is an estrogen + progesterone IVR for hormone replacement therapy.
Valued at $2.2 billioni, the U.S. hormone replacement therapy (HRT) market is largely serviced by compounding pharmacies, with no available FDA-approved combination products delivering natural hormones.
The North American Menopause Society (NAMS) recently released an updated physician statement that reiterated the benefit of hormone replacement therapy for postmenopausal women. NAMS assembled an advisory panel of experts in women’s health to review the 2012 physician statement, evaluate the evidence and reach a consensus on the best clinical practice recommendations for the use of HRT. The new data includes findings from long-term randomized clinical trials and observational studies investigating the effective HRT during and after its use. The physician statement calls for individualized treatments to identify the appropriate dose, timing of treatment, formulation and random administration for each patient to maximize human benefits while minimizing risks.
NAMS concluded that estradiol-based HRT remains the most effective therapy for symptoms of menopause and the prevention of bone loss and fracture, and that benefit-risk ratio remains favorable in women younger than 60 years old or within 10 years of menopause onset and have no contraindications to HRT. Additionally, for bothersome symptoms of menopause that are not relieved by over-the-counter therapies, non-oral therapies such as vaginal estrogen are recommended.
These conclusions underscore the importance of HRT as an appropriate treatment to address the symptoms of menopause and the need for further development of new formulation in most administration to allow for the individualized treatment for this unresearched patient population.
JNP-0201 is a two-segment IVR comprised of an estradiol segment to address the symptoms of menopause coupled with a natural progesterone segment to protect against endometrial hyperplasia. We expect JNP-0201 will follow the 505(b)(2) regulatory pathway in the U.S.
We plan to utilize the 505(b)(2) regulatory pathway in the U.S. Requisite clinical trials under this pathway would include a Phase 2 bioavailability and dose-finding study followed by a pivotal Phase 3 clinical trial.
In 2017, we plan to conduct definitive sheep studies to test the actual size and configuration of the rings in an animal model, where results are then translatable to humans. We will also continue our IND-enabling activities, all of which could support a potential investigational new drug (IND) application submission with the FDA for JNP-0201 in the first half of 2018.
i Symphony Health Solutions Report, 2014.