JNP-0101 is an investigational oxybutynin IVR for the treatment of overactive bladder in women.
Overactive bladder, or OAB, is characterized by involuntary contraction of the detrusor muscles before the bladder is full. This chronic urological condition affects an estimated 20 million women in the U.S., with approximately nine million receiving pharmacologic therapy. The domestic market for OAB therapeutics was $1.3 billion in 2014i.
Oxybutynin addresses OAB by decreasing muscle spasms of the bladder and the frequent urge to urinate caused by these spasms. The most common prescription drug is generic oral oxybutynin, but approximately half of women treated discontinue its use within the first year due to undesirable side effects. We believe that delivering oxybutynin intravaginally using our IVR technology could provide an effective treatment for the condition while improving systemic side effects.
It is expected that JNP-0101 will utilize the shared vascular and lymphatic networks of the vagina and bladder to achieve localized absorption of oxybutynin by relevant tissues in higher concentrations, while bypassing hepatic first pass metabolism. Metabolism in the liver can result in increased active metabolites, which are purported to contribute the majority of experienced side effects.
The sustained-delivery oxybutynin IVR is also expected to improve compliance, as well as increase convenience for many patients and improve disease management and overall health outcomes.
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.
We completed a pilot pharmacokinetics study in a sheep model, as defined in our pre-IND meeting with the FDA, in which an in vitro-in vivo correlation was observed. Once formulation optimization is complete, and following additional IND-enabling studies, we expect to file an investigational new drug (IND) application submission with the FDA in the first quarter of 2018.
i Technavio Insights, 2014. Global Overactive Bladder Therapeutics Market Report 2014-2018.