BioDelivery Sciences International, Inc.
) announced that it successfully concluded the meeting with the
U.S. Food and Drug Administration (FDA) to progress with phase
III studies on its candidate, clonidine topical gel. Clonidine
topical gel is being developed for the treatment of patients
suffering from painful diabetic neuropathy (PDN).
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After the company's meeting with the FDA last month, the U.S.
regulatory body gave a positive nod to BioDelivery Sciences'
proposed clinical program. The FDA also granted a fast track
designation to clonidine topical gel in the PDN indication.
The proposed clinical program includes two placebo-controlled
studies and one safety study in patients with PDN. The company
will assess the duration of the treatment required for the safety
As per the FDA's decision, BioDelivery Sciences intends to
initiate the first of the two placebo controlled phase III
studies in early 2014. Results from these studies are expected by
the end of 2014. Positive results from the study will see
BioDelivery Sciences initiating the second study in 2015.
BioDelivery Sciences plans to file the New Drug Application (NDA)
for Clonidine Topical Gel in 2016.
Apart from clonidine topical gel, BioDelivery Sciences also has
two more late-stage candidates - Bunavail and BEMA Buprenorphine.
In Oct 2013, the company's NDA for Bunavail was accepted by the
FDA. BioDelivery Sciences is looking to get Bunavail
approved as maintenance therapy of opioid dependence. A final
decision from the U.S. regulatory body on the approval of the
candidate is expected by Jun 7 next year.
Meanwhile, the company is developing BEMA Buprenorphine for the
treatment of chronic pain in phase III studies (results expected
in 2014). We expect investor focus to remain on these candidates.
BioDelivery Sciences carries a Zacks Rank #3 (Hold). Some better
ranked stocks include
Lannett Company, Inc.
AMAG Pharmaceuticals, Inc.
). While Actelion and Lannett hold a Zacks Rank #1 (Strong Buy),
AMAG carries a Zacks Rank #2 (Buy).