BioDelivery Sciences shares down on topical gel Phase III trial results

BioDelivery Sciences' shares (Nasdaq: BDSI) were down up to 30% following the drugmaker’s announcement that its clonidine topical gel did not meet the primary endpoint of its Phase III trial.

The study of 140 adults was comparing clonidine to placebo in the treatment of painful diabetic neuropathy. Patients were randomized to receive either clonidine or placebo for 12 weeks, with the primary outcome set as a change in average pain score over time.

Andrew Finn, executive vice president of product development, said: "Based on the results of our previously announced positive interim analysis, this outcome was unexpected. The interim analysis data showed a difference compared to placebo of -0.94  with a standard deviation of 2.2 which was close to our study assumption of -1.0 and 1.8, respectively, and very similar to the prior Phase II study conducted by our licensor Arcion."