This clinical trial will evaluate the safety and efficacy of COL-1077 to reduce pain experienced during and after an endometrial biopsy. This common gynecological procedure helps in the diagnosis of conditions such as abnormal menstrual bleeding, pelvic tenderness, endometrial hyperplasia, and uterine cancer.
"An estimated five to six million minimally invasive gynecological procedures are performed annually in the U.S. alone, and the pain and discomfort patients experience when undergoing these procedures is real and significant. COL-1077 is potentially an elegant solution that we expect will effectively reduce women's pain during gynecologic procedures and improve their clinical experience," said
The multicenter clinical trial will study 150 patients undergoing pipelle-directed endometrial biopsy with tenaculum placement at 15 research sites across
The study will assess the reduction in pain intensity during the endometrial biopsy and time points up to 24 hours after the procedure as compared to placebo. Safety assessments, use of "rescue" pain medications, and patient-related outcome measures, such as time to return to work following the biopsy will be also examined. Study results are expected in mid-2016.
Juniper's research and development program is guided by its
COL-1077 is the first in a series of value-creating drug compounds Juniper expects to advance into clinical development; announcement of the next product candidate is expected later this year. The specialty pharmaceutical company plans to use cash flow generated by its CRINONE® franchise and service business to substantially fund its drug development.
About Juniper Pharmaceuticals
Juniper Pharmaceuticals™ and Juniper Pharma Services™ are trademarks of
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Forward Looking Statements
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are usually indicated by the words "may," "will," "plans," "believes," "expects," "anticipates," "potential," "should," or similar expressions, and which are generally not historical in nature. These include all statements relating to the expected benefits of COL-1077 in reducing pain associated with minimally invasive gynecologic procedures and improve their clinical experience; anticipated timing to report study outcomes; and, Juniper's business strategy and expected long-term value and future growth related thereto. 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. 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
Rasky Baerlein Strategic Communications
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