BioDelivery Sciences International (NSDQ:BDSI) said today that its clonidine topical gel for pain relief in patients with diabetic neuropathy failed in a phase IIb clinical trial. Raleigh, N.C.-based BioDelivery will halt any further development of the painkiller.
In the phase IIb clinical trial, BioDelivery’s topical gel did not demonstrate a statistically significant difference in pain relief compared to a placebo. The company licensed the clonidine topical gel from Arcion Therapeutics to develop and commercialize it in March 2013.
“We clearly indicated when we embarked on this study that following the changes we made to the protocol based on previous work, that the results would support a definitive decision,” president & CEO Mark Sirgo said in prepared remarks. “We can comfortably say that the changes made to the protocol design provided us with a reliable and unambiguous data set that demonstrated that Clonidine Topical Gel, at this strength and in this delivery form, is not effective for the treatment of painful diabetic neuropathy. As such, we have no further plans for development at this time, and the $16 million that was to be directed to this program for 2017 will now allow us to extend our cash runway into 4th quarter of next year. We will focus our 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.”