BioDelivery Sciences International, Inc. BDSI announced that its phase III candidate, clonidine topical gel, failed to achieve statistical significance in a study being conducted for the treatment of painful diabetic neuropathy. BioDelivery’s shares plunged 24.3% on the news.
However, the company reported that while the study did not meet its primary efficacy endpoint, certain secondary endpoints showed a statistically significant improvement. Additionally, the candidate exhibited a strong safety profile.
The study evaluated clonidine topical gel versus placebo in patients suffering from painful diabetic neuropathy.
At the time of reporting fourth quarter results, BioDelivery had reported encouraging data from an interim analysis of the phase III study. Based on this, the company had added approximately 80 patients to the then-ongoing phase III study. However, in the current press release, the company reported that this additional group of patients performed very differently, leading to the unfavorable outcome.
Positive data from this study along with the commencement of a second phase III study could have positioned the company for a regulatory filing in the U.S. in 2016. In the U.S., the FDA granted fast-track designation for the program.
Meanwhile, BioDelivery has several regulatory events lined up this year. The company expects an FDA decision on the approval status of Belbuca (moderate-to-severe chronic pain), in the fourth quarter of 2015. The company has an agreement with Endo International ENDP for Belbuca.
BioDelivery also intends to file a data package with the FDA shortly for review so that Onsolis (breakthrough cancer pain in opioid-tolerant patients) can be reintroduced in the U.S. following a decision from the FDA by the end of 2015. In the meantime, the company expects to complete an induction study of its opioid dependence drug Bunavail and submit a supplemental new drug application for the same by the fourth quarter of 2015.
BioDelivery Sciences carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Lannett Company, Inc. LCI and Cambrex Corp. CBM. Both companies sport a Zacks Rank #1 (Strong Buy).
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