BioDelivery Sciences International Inc. said on Monday its pain drug for diabetic neuropathy failed to meet the primary goal in a Phase 3 clinical trial. Shares fell nearly 30 percent.
The drugmaker said its Clonidine topical gel was not found to be more effective than a placebo in treating the nerve-related pain.
“Based on the results of our previously announced positive interim analysis, this outcome was unexpected,” Andrew Finn, BioDelivery’s executive vice president of product development said in a prepared statement.
Chief Executive Mark Sirgo said he believes that Clonidine is a potentially effective treatment for diabetic neuropathy. “We encountered similar challenges in our early clinical development work” with other treatments and “were ultimately successful in conducting two pivotal studies that met their endpoints.
“Leveraging this experience and the aspects of this study that we believe are encouraging, we are optimistic that we can achieve a similar outcome with Clonidine topical gel,” said Sirgo.
Diabetic neuropathy is the most common complication of diabetes mellitus (DM), affecting as many as 50 percent of patients with type 1 and type 2 DM.
BioDelivery’s shares were trading at $10.09 on the Nasdaq on Monday morning, reports Reuters.
Filed Under: Drug Discovery
