FDA Agrees to BDSI's Phase III Program - Analyst Blog

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BioDelivery Sciences International, Inc. ( BDSI ) 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).

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 assessment.

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 Actelion Ltd. ( ALIOF ), Lannett Company, Inc. ( LCI ) and AMAG Pharmaceuticals, Inc. ( AMAG ). While Actelion and Lannett hold a Zacks Rank #1 (Strong Buy), AMAG carries a Zacks Rank #2 (Buy).



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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: ALIOF , AMAG , BDSI , LCI , PDN

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