Poorer than expected results of a Phase II clinical trial of vaginally-administered lidocaine announced today by Columbia Laboratories, Inc. resulted in Columbia Laboratories stocks falling.

The trial included 70 women with moderate to severe dysmenorrhea. The patients acted as their own control in the double-blind placebo-controlled clinical trial, given that a cross-over design was used. The goal of the study was to demonstrate a difference in pain intensity as determined between lidocaine and placebo.  Although the drug failed to meet its goal of relieving pain intensity over four treatment days, compared with placebo, patients tended to choose the lidocaine treatment cycle in subjective assessment regardless. The company, as a result, is evaluating the feasibility of enhancing the lidocaine effect by modifying the dosage regimen and treatment protocol.

The study showed no difference in safety for our lidocaine product candidate compared to placebo.

Columbia is developing a formulation of lidocaine administered vaginally, using its proprietary bioadhesive delivery system (BDS) technology.

Dysmenorrhea, uterine cramping and pain before and during menses and seriously affects 12% of all menstruating women in the U.S. between the ages of 20 and 45, or about 5.6 million women and is blamed for 600 million lost work hours and approximately $2 billion in lost productivity annually.

Source: Columbia Laboratories, Inc.