"The completion of enrollment in this important study represents a significant milestone for Juniper, and brings us closer to our goal of providing a safe and effective analgesic for pain and cramping from minimally invasive outpatient gynecologic procedures," said Bridget A. Martell, MA, MD, Juniper's Chief Medical Officer.
"There are over seven million such procedures performed annually in the U.S. with no standard of care for pre-treatment analgesia. Assuming positive outcomes of this study, we believe that COL-1077 could become a powerful new tool for pain management in women undergoing these procedures," Dr. Martell concluded.
The randomized, double-blind Phase 2b study compares the safety and efficacy of a single dose of COL-1077 versus placebo bioadhesive vaginal gel in women undergoing a pipelle-directed endometrial biopsy with tenaculum placement, a common diagnostic procedure. The study enrolled 187 patients at 25 centers across the U.S.
The primary efficacy endpoint in this clinical trial is the reduction in pain intensity, as recorded on the 11-point Numerical Pain Rating Scale (NPRS), at the time of endometrial biopsy.
Secondary efficacy endpoints include the reduction in pain intensity at additional time points and patient related outcomes. In addition, safety and tolerability as assessed by incidence of adverse events and clinical laboratory and electrocardiography (ECG) parameters are being measured.
In this trial, COL-1077 was self-administered by the patient approximately six hours prior to her scheduled procedure. The bioadhesive lidocaine gel adheres to the vaginal epithelium, providing sustained delivery of drug and allowing lidocaine to cross the non-keratinized epithelial lining into the endometrium and myometrium, where the endometrial biopsy procedure occurs. This sustained delivery is expected to enable the patient to arrive at her OB/GYN's office "procedure ready".
A paper describing two previously conducted 42-subject double-blind, randomized, placebo-controlled Phase 1 clinical trials of COL-1077 was recently accepted for publication by the international peer-reviewed medical journal Clinical Pharmacology in Drug Development. These single- and multiple-dose studies collectively demonstrated that in women treated with COL-1077, lidocaine was absorbed through vaginal tissue and into the systemic circulation in a dose-proportional manner, and there was little systemic accumulation. Plasma concentrations were 10- to 20-fold lower than those seen for intravenous lidocaine when administered for its anti-arrhythmic properties, thus demonstrating a wide safety margin for COL-1077.
The accepted article, "Pharmacokinetics of lidocaine and its metabolites following vaginal administration of lidocaine gel to healthy female subjects," is currently available online.
About Gynecologic Procedure Pain
An estimated seven million minimally invasive gynecological procedures are performed annually in the U.S. alone. Common procedures include colposcopy, loop electrosurgical excision procedure (
First introduced over 60 years ago, lidocaine remains a mainstay for rapid and safe anesthetic activity. While many topical lidocaine products are
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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 expected timing to report study outcomes and the potential impact of COL-1077 for the management of pain in women undergoing minimally invasive gynecologic procedures, if approved. 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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