Juniper Pharmaceuticals Announces Phase 1 Studies of COL-1077 Lidocaine Vaginal Gel Published in Peer Reviewed Scientific Journal

BOSTON, June 16, 2016 /PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a women's health therapeutics company, today announced that the international peer-reviewed medical journal Clinical Pharmacology in Drug Development has published the combined results of two Phase 1 clinical trials that demonstrated the safety and pharmacokinetics of Juniper's lidocaine bioadhesive vaginal gel, COL-1077. The abstract and accepted article are now available online at http://onlinelibrary.wiley.com/doi/10.1002/cpdd.286/abstract. 

The article reports that in women treated with COL-1077, lidocaine was absorbed through vaginal tissue and into the systemic circulation in a dose-proportional manner, with little systemic accumulation. Plasma concentrations were 10- to 20-fold lower than those seen for intravenous lidocaine when administered for its anti-arrhythmic activity, thus demonstrating a wide safety margin for COL-1077.

"These positive PK and safety studies demonstrate that COL-1077 effectively delivered lidocaine while maintaining relatively low serum levels of the drug," said Bridget A. Martell, MA, MD, Chief Medical Officer of Juniper Pharmaceuticals and lead author of this paper. "This combination of systemic absorption through local tissue administration with low lidocaine plasma concentrations suggests a unique safety-benefit profile for the product."

The publication, "Pharmacokinetics of lidocaine and its metabolites following vaginal administration of lidocaine gel to healthy female subjects," describes single- and multiple-dose double-blind, randomized, placebo-controlled clinical trials conducted to assess the safety profile of COL-1077 and the pharmacokinetics of lidocaine and its metabolites.

In these trials, normal healthy female volunteers were randomly assigned to receive:

• 2.5% lidocaine bioadhesive vaginal gel (n=12), which delivered 37.5 mg lidocaine;
• 5% lidocaine bioadhesive vaginal gel (n=12), which delivered 75 mg lidocaine;
• 10% lidocaine bioadhesive vaginal gel (n=12), which delivered 150 mg lidocaine; or,
• Placebo bioadhesive gel (n=6).

In both studies, safety and tolerability were assessed by evaluating adverse events, vital signs, physical exams, electrocardiography (ECG), and laboratory tests.

The studies demonstrated that lidocaine was effectively absorbed systemically following administration of lidocaine vaginal gel at doses of 2.5%, 5% and 10%. Mean plasma concentrations fell in parallel fashion, with a consistent elimination half-life of approximately 10 hours following peak concentrations achieved in 6 hours. 

Plasma concentrations of lidocaine at the 2.5%, 5% and 10% doses were found to be substantially lower than intravenous doses necessary for its anti-arrhythmic properties, suggesting that intravaginal lidocaine could be safely administered at the doses tested without concern for serious systemic adverse effects. In addition, minimal accumulation for lidocaine and its sequential metabolites, monoethylglycinexylidide (MEGX) and glycinexylidide (GX), was detected when lidocaine was administered daily and over four consecutive days. 

COL-1077 lidocaine vaginal gel administration was found to be safe and well tolerated, with only mild or moderate adverse events reported. Additionally, there were no clinically significant laboratory, vital sign, physical exam, or ECG findings in the active dose groups of either study.

Juniper Pharmaceuticals is currently completing a Phase 2b clinical trial evaluating COL-1077 10% lidocaine bioadhesive vaginal gel as a self-administered analgesic for minimally invasive outpatient gynecologic procedure pain. An estimated seven million minimally invasive gynecological procedures are performed annually in the U.S. alone. The Company expects to report top-line data from this study in the third quarter of 2016.

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 intravaginal 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. 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 and Quarterly Report on Form 10-Q for the period ended March 31, 2016. 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. 

Contact
Amy Raskopf
Director, Corporate Communications, Juniper Pharmaceuticals, Inc.
(917) 673-5775 / [email protected]

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Citation for this article: Martell BA et al. Pharmacokinetics of lidocaine and its metabolites following vaginal administration of lidocaine gel to healthy female subjects. Clin Pharmacology in Drug Devel. 2016 June 14. pii: S0168-3659(16)30249-8. doi:10.1002/cpdd.286. [Epub ahead of print]

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SOURCE Juniper Pharmaceuticals, Inc.

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