Researchers at Columbia Laboratories say that lidocaine failed to hit the primary endpoint in a mid-stage trial for prevention and treatment of dysmenorrheal, or painful menstruation. The therapy was no better than a placebo in treating the condition. There are no current therapies approved for dysmenorrheal.
"Data from our initial dysmenorrhea clinical study suggest a trend for a positive lidocaine effect among secondary data endpoints for the patients' overall assessments of each menstrual cycle, although the clinical trial did not show a difference between lidocaine and placebo in patient-assessed pain scores, our primary endpoint," stated Robert S. Mills, president and chief executive officer of Columbia Laboratories. "We are evaluating if it is feasible to enhance this lidocaine effect through modifications to the dosing regimen and treatment protocol. We are encouraged that the study showed no difference in safety for our lidocaine product candidate compared to placebo. Our next steps will be to conduct a full analysis of these study results and determine the best way to build on these findings."
- check out Columbia's release [1]
Links:
[1] http://www.fiercebiotech.com/press-releases/columbia-laboratories-reports-results-phase-ii-clinical-trial-vaginally-administered-