BioDelivery Sciences (BDSI) Climbs On FDA Approval


BioDelivery Sciences International, Inc. (NASDAQ: BDSI)

BioDelivery Sciences is having an incredible day in the market today after a subsidiary of the company, Endo Pharmaceuticals Inc., announced that it had received FDA approval for a new drug. Today, we’ll talk about the FDA approval, what we’re seeing in the market as a result, and what we can expect to see from BDSI moving forward. So, let’s get right to it…

BELBUCA Has Been Approved By The FDA

Endo Pharmaceuticals announced today that the United States Food and Drug Administration has approved BELBUCA. The approval is for the use of the buccal film in patients suffering from chronic pain that is severe enough to require around the clock opiod treatment and for which alternative treatment options have proven to be inadequate. BELBUCA represents a first in class treatment. It is the first buprenorphine that was created as a desolving film that is absorbed through the cheek lining. The new drug will be available in the United States market in the first quarter of 2016. In a statement, Dr. Richard L. Rauck, Director of Carolinas Pain Institute had the following to say…

The availability of new, convenient and flexible treatment options is important for patients whose lives are burdened by chronic pain, a debilitating condition that affects more Americans than diabetes, heart disease and cancer combined… BELBUCA provides a unique approach for chronic pain management, combining the proven efficacy and established safety of buprenorphine with a novel buccal film delivery system that adds convenience and flexibility. For both opiod-naive and opioid-experienced patients who require around the clock treatment and for whom alternative treatment options are inadequate, BELBUCA offers appropriate, consistent pain relief and a low incidence of typical opiod-like side effects.”

How The Market Reacted To The News

Anytime we see positive news from a biotechnology company, especially news of a newly approved treatment, we tend to see a strong, positive reaction in the market. That’s exactly what we’re seeing from BDSI today. While it is still relatively early in the day, BDSI has gained dramatically already. Currently (9:58), the stock is trading at $5.98 per share after a gain of 13.26%.

What We Can Expect To See From BDSI Moving Forward

All in all, I have a bullish opinion of what we can expect moving forward from BDSI. The reality is that the new approval for BELBUCA is likely to drive incredible profits for the company. As mentioned by Dr. Rauck, chronic pain is a condition that affects more patients than cancer, heart disease and diabetes combined. The reality is that the market for such a treatment is absolutely astronomical. Even if BDSI could only penetrate 1% of the chronic pain market, which I believe would be an incredible understatement, the company would stand to gain billions of dollars in sales. While BDSI has yet to report positive earnings for any quarter, I believe that the new treatment has the potential to change that. Overall, with the new FDA approval on the books, I think that we’re going to see incredibly positive movement both in the short and long term outlook from this stock.

What Do You Think?

Where do you think BDSI is headed and why? Let us know in the comments below!

[Image Courtesy of Benzinga]


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