"It was a very collaborative meeting," commented Dr.
Overactive bladder 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
Oxybutynin addresses OAB by decreasing muscle spasms of the bladder and the frequent urge to urinate caused by these spasms. While the most common prescription drug is generic oral oxybutynin, approximately half of women treated discontinue its use within the first year due to undesirable side effects. Juniper believes that delivering oxybutynin intra-vaginally using its 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.
Juniper plans to utilize the 505 (b)(2) regulatory pathway in the U.S. Requisite clinical trials under this pathway would include a Phase 2a bioavailability and dose finding study followed by a pivotal Phase 3 clinical trial.
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Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the timing of the IND filing and Phase 2b clinical trial for JNP-0101; the potential of JNP-0101 to be an effective treatment for overactive bladder, to improve systemic side effects versus generic oral oxybutynin, to improve compliance, to increase convenience, and to improve disease management and overall health outcomes in overactive bladder patients; the intended use of the 505(b)(2) regulatory pathway in the Unites States; and anticipated clinical trials under this regulatory pathway. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the drug development process generally, including the outcomes of planned clinical trials and the regulatory review process; the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies or following commercial launch, if such product candidates are approved; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with
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i Market data source: Technavio Insights, 2014. Global Overactive Bladder Therapeutics Market Report 2014-2018.
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