March 30, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Raleigh, N.C.-based BioDelivery Sciences International announced today that its Phase III clinical trial of Clonidine Topical Gel failed to meet its primary endpoint.
The trial compared Clonidine Topical Gel to placebo for the treatment of diabetic neuropathy. It failed to show statistically significant improvement for primary efficacy. However, the company reports that the compound demonstrated a strong safety profile and various secondary endpoints showed statistically significant improvement over placebo.
“Based on the results of our previously announced positive interim analysis, this outcome was unexpected,” said Andrew Finn, executive vice president of Product Development at BioDelivery in a statement. “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.”
The company’s stock a dive at the news. Company shares have been, for the most part, on a relatively steady rise for much of the year. On Sept. 12, 2015 stocks sold for $18.15. It dropped on Jan. 15, 2015 to $11.75, and on Friday, March 27, 2015, was selling for $13.01 prior to the news of the study failure. The current share price is $9.50.
Although this was not good news, the company has other things going on that should supply some stability. The company’s drug Bunavail (buprenorphine and naloxone buccal film) was launched recently. It was approved by the U.S. Food and Drug Administration (FDA) in June 2014 for maintenance therapy for opioid dependence. In its fourth quarter report on March 16 the company noted that 10,000 prescriptions for Bunavail had already been dispensed.
The company also indicated it had reacquired North American marketing authorizations for the company’s first FDA-approved product, Onsolis, which is used for the management of breakthrough pain in opioid tolerant cancer patients. In addition, the company inked an exclusive deal with Evonik Corporation for injectable buprenorphine formulation for opioid dependency treatment, as well as for chronic pain.
“The past year has been a transformational one for BDSI with multiple key milestones achieved and significant stockholder value created,” said Mark Sirgo, president and chief executive officer in a statement.
The company has a partnership with Endo Pharmaceuticals , which together have a new drug application (NDA) for Belbuca accepted and are hoping for approval later this year. That approval would trigger up to an additional $50 million milestone payment from Endo.
Regarding the most recent trial, the company indicates they are still optimistic. “We believe the results of this trial continue to support that Clonidine Topical Gel is a potentially effective treatment for painful diabetic neuropathy and an important advance in treatment,” said Sirgo in a statement. “We encountered similar challenges in our early clinical development work with BEMA Buprenorphine for chronic pain and were ultimately successful in conducting two pivotal studies that met their endpoints.”
