BDSI - addiction contract

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Bunavail vs. Suboxone: What’s the Difference?
Both Bunavail and Suboxone list buprenorphine as the main ingredient. In a clinical trial of the drug, 249 patients were switched from the latter to the former. The majority reported that the drug was easy to use and pleasant tasting. They also said they felt less constipated, which is a common side effect of opiate detox. And their urine tested clean of illegal drugs.

Suboxone is a sublingual film that slowly dissolves under the tongue. In contrast, Bunavail is a buccal film that dissolves on the inside of the cheek. BDSI notes that this makes it easier to talk during treatment. The major advantage is that the new formulation has improved absorption into the bloodstream, so it only takes half the amount of buprenorphine to work.
 






You had me at constipation......

BEMA® – Advanced Technology - Patient Benefits
The BEMA difference – first and only buccal film
Efficient delivery
 2X bioavailability of buprenorphine vs Suboxone; less drug - same plasma concentration  May limit potential for misuse/diversion; potentially lessen incidence of certain side effects
Effective and well tolerated delivery over the course of a 12 week study
 Only 8% of patients had a positive urine test for non-prescribed opioids
 Patient retention was high (>79%)
 68% experiencing constipation on Suboxone saw resolution when switched to BUNAVAIL
Easy and convenient for patients to use
 Film adheres in seconds; patients free to speak and go about normal activities  > 8 out of 10 patients – rated use as very easy, easy or neutral
 > 9 out of 10 patients – rated taste as very pleasant, pleasant or neutral
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As an Addictionologist, I don't care about taste or constipation, bottom line is efficacy.
The last thing my patients need to worry about is taste or constipation. As far as bioavailability goes, there are no studies comparing your product or Zubsolv to Suboxone film. I've also been informed that it takes the buccal to dissolve in 30 min. My patients on film tell me it takes 10-15 min to dissolve. When the Bunavail rep comes to my office going on and on about less medication, better taste or less constipation, they will not be allowed back. Come to me with new information that can help my patients.
 












Anonymous said:
As an Addictionologist, I don't care about taste or constipation, bottom line is efficacy.
The last thing my patients need to worry about is taste or constipation. As far as bioavailability goes, there are no studies comparing your product or Zubsolv to Suboxone film. I've also been informed that it takes the buccal to dissolve in 30 min. My patients on film tell me it takes 10-15 min to dissolve. When the Bunavail rep comes to my office going on and on about less medication, better taste or less constipation, they will not be allowed back. Come to me with new information that can help my patients.
Click to expand...

Uh huh.... Do you really think that anyone believes that you are an MD? Bottom line is efficacy, right? Same active ingredients with fewer side effects and higher bioavailability equals better compliance which results in better outcomes. If you don't think your patients worry about taste or constipation or other side effects then you are a complete idiot. Then obviously you do not care about patient compliance. And without compliance, it doesn't matter how good or bad the drug is. Have you ever been constipated? Obviously you have, because your post indicates that you are full of shi$.
 


















clinical study on 249 subjects which were dependent on opioid was performed prior to the NDA submission. Results showed that the majority of the patients who switched from suboxone tablets or film strips to the BUNAVAIL found it easy to use and liked its taste. The drug’s BDSI’s Executive Vice President of Product Development Dr. Andrew Finn stated that these are two important qualities that may signify opioid treatment improvements over other existing therapies.

Executive Vice President of Product Development
Andrew L. Finn, Pharm.D., has been our Executive Vice President of Product Development since January 2007. He joined the company in August 2004 upon our acquisition of Arius Pharmaceuticals, of which he was a co-founder. Dr. Finn has previously served as our Senior Vice President of Product Development and Executive Vice President of Clinical Development and Regulatory Affairs. Dr. Finn has over 30 years' experience in pharmaceutical product development. Prior to his involvement with Arius, he was, from 2000 to 2003, Executive Vice President of Product Development at POZEN Inc. with responsibilities for formulation development, non-clinical development, clinical research and regulatory affairs. He participated in the POZEN activities leading up to the initial public offering and submitted marketing applications in Europe and the U.S. for two migraine products. From 1996 to 1999, Dr. Finn was Co-Founder and Chief Executive Officer of enVision Sciences, a regulatory and clinical service company. From 1991 to 1996, he was Vice President of Clinical Research and Biometrics for Solvay Pharmaceuticals, where he oversaw NDA submissions in the areas of inflammatory bowel disease, osteoporosis prevention and treatment of obsessive-compulsive disorder. Prior to this, he spent 10 years in positions of increasing responsibility at Glaxo Inc., where he oversaw a number of NDA submissions, including Zofran for chemotherapy induced nausea and vomiting. Dr. Finn is qualified to serve on our management team because of his extensive experience in specialty biopharmaceutical companies. Dr. Finn received his BS in Pharmacy from the University of North Carolina and his Doctorate from the University of Michigan.
 






Purpose of previous post:

Show that study was done on patients that were on sub tablets or film.

Taste and constipation DO matter to the patients.

Granted, the Finn represents BDSI, but you have to admit, he has quite the resume and background with new drug submissions.

But I see he doesn't have any background as an addictionologist. Don't hold that against him.

We all want to provide the best solutions.

Let's try to keep an open mind in connection with new products. Time will tell if this solution provides a meaningful alternative to providers and patients.
 






When you're in recovery the LAST thing that physicians or patients think about is taste!
It's about efficacy, not if it tastes like menthol or coffee. Zubsolv has the same studies that talk about taste and you see how far that got them.
 






I agree that efficacy must be present.

Bunavail had only 8% of patients in their study with a positive unrine test over 12 week study.

Also, patient retention was >79%.

Don't know why zubsolv has weak sales. I'm open to the possibility that bunavail may be a viable alternative, and possibly a superior alternative to suboxone.
 






Zubsolv has weak sales BECAUSE IT DOES NOT WORK. Physicians and patients will not go for the higher bioavailability less medicine line again. You can thank zubsolv for that, they've ruined it for anyone that claims this. Patients are relapsing, physicians are pissed and WILL fight to keep patients on Suboxone film.
 






You may want to look at the Suboxone film ONE year retention study along with the low number of positive urine screens. They'll blow Bunavail's 12 week study right out of the water.
Not only with the length of studies, but the number of patients as well. It all boils down to efficacy and keeping patients in treatment!!
 






In the study, more than 600 treatment-seeking outpatients addicted to prescription opioids received Suboxone in combination with brief standard medical management, in which physicians evaluated treatment effectiveness and recommended abstinence and self-help participation. Half of the participants also received varying intensities of addiction counseling as provided by trained substance abuse or mental health professionals.

Results showed that approximately 49 percent of participants reduced prescription painkiller abuse during extended (at least 12-week) Suboxone treatment. This success rate dropped to 8.6 percent once Suboxone was discontinued. Reductions in prescription painkiller abuse were seen regardless of whether or not the patient reported suffering chronic pain, and participants who received intensive addiction counseling did not show better outcomes when compared to those who did not receive this additional counseling.
 






Please get your facts in order prior to additional postings.

1. Bunavail study WAS against sub film AND tabs.

2. 12 week study indicated 8% failure vs 51% in study identified in previous post.

I'm delighted to have an intelligent discussion of facts. I'm wasting valuable time correcting your incorrect and slanted comments.


I hope patients are aware of their choices of medications,.... as well as providers.
 






Hmmm , 8% failure for bunavail? VS 52% failure of suboxone? Anyone who disputed the studies is an idiot. Or better yet, a suboxone salesman. Doesn't come across as an addictionlogist. More like a cosmetologist. Apologies to any cosmotologists who may be reading this board.
 
























I'm very sorry that didn't get hired...

There will be other jobs for you.

There are special programs and medicines available to help you control your anger issues.

Just keep repeating to yourselves, I'm a good person, and people like me.
 






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