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Titan Pharmaceuticals Inc. Message Board

  • jrange7798 jrange7798 May 5, 2013 2:01 PM Flag

    the blood plasma level

    So basically the 12/16mg dose prescribed to suboxone patients only about half of that actually gets in the bloodstream. And the reason why they use more than the amount that enters into the bloodstream, is it speed sup the proces. So titan doesn't need to make rods that can hold enough to release 16/12mg a day. But maybe. Half. So if need be patients could get implants in both arms. To me I think that's what the fda wants titan to try. But then of course that's more trials.

    Sentiment: Hold

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    • From the AdCom briefing documents, section 3, Clinical Pharmacology, the PRO-810 study looked at plasma levels and found AUC0-24 level of 62.7 ng-hr/mL for sublingual buprenorphine (16 mg/day), and 19.6 ng-hr/mL for Probuphine implant (4 x 80 mg rods), or 31.3%. 62.7 ng-hr/ml *4200 mL blood in average male's body*24 hr = 6.3 mg of the original 16 in the blood available over one day (with peaks and valleys with each tablet under the tongue). Probuphine provides 31.3% of that, or 2.0 mg per day, at a steady, constant dose. Most likely, there is a threshold blood plasma level below which cravings intensify, u-opioid receptors aren't partially activated, etc... My bet is that level is below the steady plasma level induced by Probuphine.

      I would love to see an hourly cravings diary compared to hourly buprenorphine plasma levels.

      We have the same issue with dopamine and Parkinson's disease. Steady plasma levels of dopamine are the key. "Pulsatile" dopamine fluctuations with pill popping in PD causes "ON"-"OFF" motor fluctuations, dyskinesias, etc... whereas a steady level of dopamine would put a patient in the "ON" state / good state all the time, and require much less dosing as well I believe.

      IMO, FDA are morons not to see that this product works just as well as sublingual buprenorphine, while reducing the amount of abusable form of buprenorphine by ***96%*** (average Probuphine patient used 12.5 8 mg rescue tablets of 6 months vs. someone taking the usual 336 tablets over the same time period).

    • j range,, what novie and bealte would say is,, once you get the rod and your 2 mgs a day,, if you take some suboxone you can finally get to the range you need? then one might ask (and be attacked for it) why would you use probuphine then?

      • 1 Reply to lovebumper.50cents
      • I wouldn't say that. I'd say the dose is fine as it is. It was proven effective vs. 12-16mg of Suboxone.

        A patient may think they need 5 rescue pills over a 180 day period, but they probably don't need it.

        4 implants is an effective dose that works for almost every patient. There is no comparable dose of Suboxone because the treatment isn't the same.

        Take out the rescue meds and Probuphine would look even better in terms of meeting the primary endpoints. If the need of 5 rescue pills, for 40-60% of patients, is enough to skew the results I would be surprised. The need for rescue meds for the placebo group would dramatically affect the results.

    • I was thinkin to myself wow this topic already got a bunch of hits.but u giys are arguing. Lol funny. To be honest my comment was more of a question than a comment. But I guess I was rite. Can't really tell from all the responses...that was funny

    • How do you factor in the fact that most patients break their treatment up. So, instead of taking 1 16 mg pill, they'll take 4 4mg doses.

      That way, they maintain a dose that is semi stable, and low, throughout the day.

      There are so many complicated variables to this treatment that it is almost impossible to do what the FDA asked.

    • jrange,, thats what i ve been syaing for 2 yrs plus,, and its bad engineering,, they basicly came up with one prototype thats suppose to fix all, does bayer aspirins have a small dose and a large dose? could u imagine bayer walking into fda office and say we have a .05 mg aspirin pill but if u need .70 mgs use milk it helps the pills go down?

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