BOSTON, March 21, 2016 /PRNewswire/ -- Juniper Pharmaceuticals, Inc. (NASDAQ: JNP) ("Juniper" or the "Company"), a women's health therapeutics company, today confirmed that it met with representatives of the Food and Drug Administration ("FDA") in a Pre-IND meeting concerning JNP-0101, its oxybutynin intra-vaginal ("IVR") for the treatment of overactive bladder ("OAB") in women.
"It was a very collaborative meeting," commented Dr. Bridget Martell, Chief Medical Officer. "The regulatory path for JNP-0101 is clear, and we are on track to complete our IND-enabling preclinical work for this promising product candidate and file our IND application later this year. We plan to begin a Phase 2a bioavailability and dose finding clinical study once the IND is active."
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 $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. 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.
About Juniper Pharmaceuticals
Juniper Pharmaceuticals, Inc. is focused on developing therapeutics that address unmet medical needs in women's health. The Company is advancing a pipeline of proprietary product candidates that leverage novel intra-vaginal drug delivery technologies. Juniper's commercial product, CRINONE® 8% (progesterone gel), is marketed by Merck KGaA, Darmstadt, Germany, in over 90 countries worldwide and by Allergan, Inc. in the U.S. Please visit www.juniperpharma.com for more information.
Juniper Pharmaceuticals™ is a trademark of Juniper Pharmaceuticals, Inc., in the U.S. and EU.
CRINONE® is a registered trademark of Merck KGaA, Darmstadt, Germany, outside the U.S. and of Allergan, Inc. in the U.S.
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 Juniper Pharmaceuticals' ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from currently approved therapies and from other companies developing products for similar uses; risk associated with Juniper Pharmaceuticals' ability to manage operating expenses and/or obtain additional funding to support its business activities; and risks associated with Juniper Pharmaceuticals' dependence on third parties. For a discussion of certain risks and uncertainties associated with Juniper Pharmaceuticals' forward-looking statements, please review the Company's reports filed with the SEC, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2015. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management's current expectations and Juniper Pharmaceuticals does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.
Director, Corporate Communications, Juniper Pharmaceuticals, Inc.
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i Market data source: Technavio Insights, 2014. Global Overactive Bladder Therapeutics Market Report 2014-2018.
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SOURCE Juniper Pharmaceuticals, Inc.