Juniper Pharmaceuticals Expands Lead Phase 2b Trial

Juniper Pharmaceuticals, Inc. (NASDAQ:JNP) announced the expansion of its lead clinical trial, and the submission of a pre-IND meeting request with the FDA for its oxybutynin intra-vaginal ring (IVR) for treatment of overactive bladder.
The company updated on its recent activities:

Intra-Vaginal Rings (IVR)
JNP-0101 – Oxybutynin IVR
Juniper has requested a pre-IND meeting with the FDA for JNP-0101, its oxybutynin IVR for the treatment of overactive bladder (OAB) in women.  The company currently plans to conduct a Phase 2a bioavailability and dose finding study in the second half of 2016. Assuming positive Phase 2 results, a Phase 3 clinical trial is expected to begin in the first half of 2017. This development program is intended to satisfy the regulatory requirements for approval and will follow the 505(b)(2) regulatory pathway.
JNP-0201 – Progesterone/Estrogen IVR
Prototype development is in progress for JNP-0201, a natural estrogen and progesterone product candidate utilizing the multi-segmented capability of Juniper’s IVR for hormone replacement therapy (HRT) in women. An IND submission is planned in 2017.
JNP-0301 – Progesterone IVR
Juniper intends to meet with the FDA in the first half of 2016 to discuss the regulatory pathway for the development of a vaginal progesterone product candidate for the prevention of preterm birth.  Development of the JNP-0301 formulation will benefit from the work being done on JNP-0201.
 

Frank Condella, CEO of Juniper Pharmaceuticals said:

Juniper’s key product candidates have progressed considerably over the past few months. We continue to expect top-line data from our Phase 2b lidocaine gel trial in mid-2016, and have advanced all three of our recently disclosed intravaginal ring development programs.
We are well positioned to use our growing cash flow from our base business and strong year end cash position to fully fund our 2016 operations and planned R&D activities internally. With successful execution of our current operating plans, we expect to launch three new products within the next five years with a combined potential market opportunity well over $1 billion.

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