BioDelivery Sciences International, a specialty pharmaceutical company, announced that phase 3 clinical study of Clonidine topical gel did not met the statistical significance.

Clonidine topical gel was compared to placebo in the phase 3 study for the treatment of painful diabetic neurology.

On one hand where the results were not favorable in the primary efficacy endpoint, certain secondary endpoints showed statistically significant improvement over placebo.

In addition, a strong safety profile for the product was observed. The company said in a statement that the results of the trails will allow them to refine the protocol criteria to capture a more 'enriched' patient population and target site selection.

Dr. Andrew Finn, executive vice president of product development stated that the results of this clinical study were quite unexpected.

"The interim analysis data showed difference compared to placebo of -0.94 with standard deviation of 2.2 which was close to our study assumption of -1.0 and 1.8, respectively, and similar to prior phase 2 study conducted by our licensor Arcion", he said.

Based on interim analysis, they added approximately 80 patients to the study. This cohort of patients performed very differently than those assessed in the interim analysis, said Dr Finn.

He also said that they are quite confident that the data from this latest study will provide them with the necessary information that is importantly required to enhance patient entry criteria, patient recruitment, and site selection.

Dr. Mark A. Sirgo, president and chief executive officer said in a statement that they believe that the results of this trail continue to support that Clonidine topical gel is a potentially effective treatment for painful diabetic neuropathy and is also important advance in treatment.

He further said that they also faced some similar problems in their early clinical development work with BEMA Buprenorphine for chronic pain but were ultimately successful.