Clonidine Topical Gel fails trial to treat painful diabetic neuropathy and programme is discontinued.- BioDelivery Sciences International.
BioDelivery Sciences International, Inc.( BDSI ) has announced that its Phase IIb clinical study assessing the efficacy and safety of Clonidine Topical Gel for the management of painful diabetic neuropathy failed to show a statistically significant difference in pain relief between Clonidine Topical Gel and placebo. As a result, BDSI is discontinuing further development of the product at this time.
BDSI will focus its R&D efforts on two important and exciting programs for our buprenorphine 30-day injection product in development - opioid dependence and chronic pain. Both are areas complimentary to Belbuca and Bunavail, where buprenorphine efficacy has previously been established with other products, and BDSI has considerable clinical expertise and regulatory experience with FDA.
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