Diabetic Neuropathy Gel Fails Clinical Trial


Clonidine topical gel fails to achieve desired outcome in reducing pain from diabetic neuropathy.

Biodelivery Sciences recently announced clonidine topical gel failed in a phase 2b clinical trial for the treatment of painful diabetic neuropathy.

Millions of individuals worldwide have diabetes, with many experiencing neuropathy, which typically occurs in the feet. Patients with painful diabetic neuropathy experience debilitating pain that may affect day-to-day activities and impair quality of life.

Currently, there are no approved topical treatments for this condition, and oral treatments are only modestly effective.

In a clinical trial that examined efficacy and safety, clonidine topical gel failed to show a statistically significant reduction in pain compared with placebo, according to a press release from Biodelivery Sciences. The company has since discontinued further development of the drug, which resulted in an anticipated $16 million in plan savings for 2017.

Clonidine is thought to work by decreasing the excitability of functional nociceptors in these patients, therefore, reducing the level of pain experienced, the company said.

"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," said Dr Mark A. Sirgo, president and chief executive officer. "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 fourth quarter of next year."

Instead, Biodelivery Sciences plans to invest their efforts into a burprenorphine 30-day injection to treat patients with opioid use disorder and pain.

“We will focus our R&D efforts on 2 important and exciting programs for our buprenorphine 30-day injection product in development - opioid dependence and chronic pain,” Dr Sirgo said. “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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