the dosing issue?
1) Can TTNP explain it?
2) Can Braeburn explain it?
3) Can Dr. Ling explain it?
4) Can the JAMA explain it?
5) Can the NIH explain it?
Tests have been developed and performed to deliver a "daily maintenance dosage" of Probuphine to a target number of addicts, but not all. When these tests were first designed, how were the dosage protocls determined and it stands to reason that safety and effectiveness were the focal points for treatment? Could it be that the FDA doesn't understand the science and TTNP simply cannot adequately explain it? Is that where we're at? If so, what in the world happens at all of the presentations made by TTNP? What to they talk about? What obvious questions are fielded and answered regarding dosage? They are making presentations to empty charis, are they? All of this is EXTREMELY difficult to understand and comprehend right now. Nothing is making sense........
I do not agree with Novak. I am a pain medicine specialist an give suboxone to my patients. The concept is totally different. Before getting on suboxone (Buprinorphine and Naloxone) the patient has to be in frank opiate withdrawal before placing them on suboxone as the naloxone would place them into withdrawal anyway. The buprenorphine is then titrated up slowly until the withdrawal symptoms have abated. this is the dose that the patient remains on. This Induction, as they call it, individually determines each patient's daily dosage. Probuphine has no naloxone and doesn't require a period of frank withdrawal(brutal for patients). The indwelling rods that contain buprinorphine just decrease craving for opiates and decrease the high if opiates are taken as they compete for the opiate receptors in the brain. The result is less reward and less satisfaction and eventually less desire for opiates. All doses of buprenorphine would work to some extent. so exact dosing is not that big an issue as seen with Butrans which starts all on a 5mg patch (placed once weekly) and then titrates up to 10 then 20mg patch max . Thus you see titan just needs to present a procedure to determine optimum doses individually. I believe they already do this The main point is all doses will work. The doctors at Titan just need to explain this to them. ie suboxone uses different rules than Titan,s drug. This is a short setback.
Sentiment: Strong Buy
Thank you for the explanation and your kindness to share it. I hope others will chime in questions for you and I hope you will be kind enough to continue to share your thoughts and educate us in what appear, to the layman, to be the nuances of dosing patients. What is your opinion of Probuphine? Do you like it as an alterntive treatment and think it should be approved in present form? Also, what is your opinion of the difficulties associated with implanting the rods? Many people are disappointed today, so your taking the time to post here is a big help to many of us. THANKS, again!
I've always been perplexed to the universal dosing method. Shouldn't the amount given be in accordance with the patient's addiction/tolerance level? I'm no scientist, but that would seem a better way to determine efficacy to me.
Stalyon: Each rod contains 80-90 milligrams of buprenorphine. Take 180(6 mos.) divide it by 90 and it equals 2Mg. per day. 4 x2mg.=8 mg.per day. This information has been available to the FDA forever. They gave guidance,accepted the NDA through the 505(b)2 exception which enabled Titan to use data from previous trials to satisfy the 500 patient requirement. The trials demonstrate non-inferiority to existing products containing buprenorphine. There's obviously an equivalency issue. Two millgrams continuously released is equivalent to far more in pill form. In effect the FDA is now saying we want you to investigate all dosages that might be required to treat all addicts. Treating some effectively is not enough.
That's preposterous. Almost no drug would be approved if that standard were used.
Is Nowak still here? Maybe he has some insight. He has been surprisingly quiet. It makes no sense to me either. The FDA complained before Adcom that dosing was too small; yet, at Adcom, some complained the dosing didn't go small enough. They probably will need more than one rod design to accommodate everyone. It makes me think corruption in the FDA. Someone paid off to reject. A very suspicious and flimsy excuse to not approve. Still, I believe they will get approval after jumping through a few more hoops.
We will not get approved if we have to do what the FDA is asking for.
It isn't a viable treatment if the dosage needs to be equivalent to 12-16mg. Who would want 10-15 implants?
We shouldn't have to prove that, either!!!!! It's really beyond me. This isn't Suboxone. However, they are trying their hardest to say it should be.