The completed study was designed to evaluate both the blood levels obtained by, as well as the relative safety of, three doses of lidocaine formulated with Columbia’s patented bioadhesive vaginal gel. Positive clinical outcomes of one of these doses were reported in a prior pilot study earlier this year.
The present study showed that each of three doses studied produced blood levels well within an accepted range. The pharmacokinetic profile produced by the company’s formulations support the administration of a single dose.
“The results of our work provide the foundation for moving forward with a once-a-day dosing regimen in dysmenorrheic patients. The positive clinical effects seen in our pilot study coupled with the relatively low blood levels in this pharmacokinetic study reflect the first uterine pass effect response specifically provided by our patented technology,” said Fred Wilkinson, Columbia’s president and CEO.
Results from the present pharmacokinetics study will determine the appropriate doses for the phase II investigation now scheduled to start in the fourth quarter of 2005.
Dysmenorrhea is characterized by recurrent uterine cramping and pain during, and sometimes just before, a woman’s period. Symptoms usually last two to three days. This condition affects nearly one in six women worldwide, and is the leading cause of workplace and school absences.