BioDelivery Sciences Reacquires License to BELBUCA™ from Endo Pharmaceuticals

BioDelivery Sciences Reacquires License to BELBUCA™ from Endo Pharmaceuticals

By Ed Coghlan

Sometimes, it’s just better doing it yourself.

BioDelivery Sciences International, Inc. (BDSI) announced that it has terminated its licensing rights for BELBUCA™ (buprenorphine) buccal film with Endo Pharmaceuticals, Inc. (Endo). This follows a strategic decision made by Endo regarding their U.S. branded pain business.

Because of the agreement, the world-wide rights to BELBUCA will be transferred back to BDSI on January 2017.

“BELBUCA provides a number of important patient benefits. BELBUCA is one of the only Schedule III options for chronic pain management, meaning it has less abuse and addiction potential compared to Schedule II products,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. “BELBUCA has also been shown to have a good tolerability profile and is available in a range of doses to meet the analgesic needs of a wide range of patients.

Dr. Sirgo thinks this gives his company more flexibility and profit potential in helping treat chronic pain.

“Now with BELBUCA and BUNAVAIL, our drug for the treatment of opioid dependence, BioDelivery Sciences is well-positioned to provide healthcare providers and their patients a responsible solution for the treatment of chronic pain while also addressing the widespread concerns over the growing problem of opioid abuse, addiction and overdose in this country.”

While BDSI plans to provide additional details on its commercial plans for BELBUCA at an event in late January, significant physician targeting work has identified the early and most likely adopters of BELBUCA. BDSI will initially leverage its existing sales force and capitalize on commercial synergies with BUNAVAIL for a focused commercial approach targeting identified healthcare providers which BDSI believes creates the potential to incrementally grow BELBUCA sales without the requirement of significant resources. BDSI will also explore other options for longer-term growth for BELBUCA both within and ex-U.S.

Given what the company says are greater long-term commercial and profitability opportunities with BELBUCA, BDSI will transition its primary commercial emphasis to BELBUCA while BUNAVAIL efforts will be limited to current BUNAVAIL prescribers and on driving sales from upcoming and future managed care contracts.

Dr. Sirgo concluded, “We believe BELBUCA is well positioned to provide healthcare providers and their patients a responsible solution for the treatment of chronic pain while also addressing the widespread concerns over the growing problem of opioid abuse, addiction and overdose in this country. BELBUCA provides important patient benefits and is well differentiated from other opioids. And as such, we believe BELBUCA has promising growth potential and the ability to add tremendous value to our company.”

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Authored by: Ed Coghlan

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It’s wonderful to hear that you have had success with herbal remedies. It’s not that way for everyone


Kristi- I think we should advocate for a better future- including those treatments you claim are years away for chronic pain patients. If we dnt advocate for a better future- how can we expect others will? And yeah- i did advocate for stem cells in the NPS- and yeah they changed the goal to include curative treatment. And thats more then proof of concept change.
Let us not be overconformed to the status quo. Let us dream boldly and have the moral imagination andmotivational intensity and the caritas to make those dreams reality. If not us, then wh will do the dreaming and the caring for us?
The future belongs to those who believe in the beauty of their dreams. If we just focus on what is readily available - it is very likely the future wont be much different or better than the sorry state of affairs in pain care that currently exists.
Its time people in pain and those that claim to care about them realize their passivity and their unwillingness to lead pain care in America is part of the problem. Its time for people in pain to realize the strength in their numbers and to mobilize and take over pain care in this country and create a new world- a world that cares about people in pain and moves rapidly toward a much better future for all in pain.


When a drug starts as a natural substance such as marijuana I prefer to use it in its most natural form. When you break it into separate chemicals I don’t feel it is a safe or effective.

Kristi M

Tom, Butrans is generally used for chronic pain and not acute. I would definitely ask for something different.

Dave, I understand what you are saying but those treatments you mentioned are probably still years away for the average chronic pain patient.


I agree Dave. Medical Marijuana with the Cbds and other components. Other natural, organic analgesics, e.g., Kratom.

Tom Sorrell

Buprenorphine Does Absolutely Nothing to Alleviate my post laminectomy pain…


I cant get excited about new and improved opioids. Even if opioids were unabusable they are suboptimal and will have side effects. And I feel the same way about improvements in anti-inflammatories or anticonvulsants. It reflects suboptimization of pain care and that pain care is essentially outworn 1960s medicine.
Now that NIH wants to use genetic medicine we may see MiRNA drugs. But it will still be conceptually the same pain care treatment. Stem cell therapy is conceptually different and has had much better results- but it has its dangers.
We need a new paradigm for pain care that is a real departure from the past.