"We are disappointed that COL-1077 did not achieve the desired effect in this clinical trial. We believe the study was well-designed and -conducted, and has adequately tested our hypothesis," said Dr.
"Based on the results of this trial, we are discontinuing development of COL-1077," said
Juniper's IVR programs are led by JNP-0101, an investigational oxybutynin IVR for the treatment of overactive bladder (OAB) in women. Roughly nine million women receive pharmacotherapy for this chronic condition in
"We expect to fund our operations and planned R&D activities with cash flows generated by our core business. We expect ongoing strong performance from the Crinone® franchise and Juniper Pharma Services," Ms. Secor added.
"We remain committed to delivering value-added treatments that meet the unique and underserved healthcare needs of women," Ms. Secor concluded.
COL-1077-07 Study Design
This Phase 2b randomized, double-blinded, placebo-controlled, multi-center clinical trial was designed to evaluate the safety and efficacy of COL-1077 10% lidocaine bioadhesive vaginal gel compared to a placebo bioadhesive gel for the reduction of pain intensity in women undergoing pipelle-directed endometrial biopsy with tenaculum placement. The primary efficacy endpoint was reduction in pain intensity at the time of endometrial biopsy on a validated 0-10 Numerical Pain Rating Score (NPRS), with secondary endpoints assessing the reduction in post-procedural pain and cramping over a 24-hour time period.
The trial enrolled 187 women (39 to 74 years old) at 25 sites across the United States. Patients were randomized on a 2:1 ratio to receive either COL-1077 10% lidocaine bioadhesive vaginal gel or placebo bioadhesive gel. Patients self-administered the gel approximately six hours prior to the scheduled outpatient appointment.
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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 strength of Juniper's core business and expected cash flows from this business; anticipated expenditures in future periods; the development of new product candidates; and the potential of Juniper's proprietary drug delivery platforms and product candidates; the expected timing of results of the JNP-0101 pilot study; and, Juniper's ability to leverage the 505(b)(2) pathway for product candidates. 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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