Opioid Ad Com

Discussion in 'Pfizer' started by anonymous, May 15, 2016 at 8:01 PM.

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  1. anonymous

    anonymous Guest

    Why has the ALO-02 Advisory Comm meeting been postponed again? Come on! It's just a simple question. Either the product releases too much naltrexone with ordinary use or it doesn't. Stand up and take a position!!! :/
     

  2. anonymous

    anonymous Guest

    Will the Ad Com include a review of Embeda? Anyone know?
     
  3. anonymous

    anonymous Guest

    Yes, if naltrexone release is the issue.
     
  4. anonymous

    anonymous Guest

    I think the issue is more than just naltrexone leakage from these products. The FDA and Advisers are going to what to know how a product that releases oxycodone too slowly and naltrexone too haphazardly,compared with OxyContin, would benefit the average pain patient when it puts the patient at risk for opioid withdrawal.

    It could be back to the reformulation desk for ALO-02.
     
  5. anonymous

    anonymous Guest

    Give it back to Alpharma. They knew how to sell it.
     
  6. anonymous

    anonymous Guest

    The country if facing a opioid abuse epidemic. If you are designing a formulation to kill addicts with naltrexone it won't fly. Maybe the majority of politicians are addicted to opioids?
     
  7. anonymous

    anonymous Guest


    TRUMP TWEET

    I need to tell you people, the country is facing a UUUGE problem, and it's only going to get worse. It's going to get worse, folks. You got terrorists, drug smuggling mexicans, and lyin-lipwack selling opoiods to our children. And there's nothing they can do about it. Because they're stupid. Very stupid people we have in charge. I am going to make things right! You're going to love working for Pfizer again. Trust me. No more lyin-Liddy or crooked Hillary, or little Bimarco running around making trouble for everyone at Pfizer. No, we're done with ..... No! Get em outa here. GET EM OUT!!! Get em outa here. F_K em. Don't give em his badge back. Keep his badge. He's a LOOOSER!!! Damn trouble maker!!!
     
  8. anonymous

    anonymous Guest


    ... and I am willing to debate, debate anyone in the opioid program for the right price. ALO-02 leaks naltrexone like a sieve, like a friggin sieve, and there's nothin nobody can do about it. Cause they're stupid folks. Very stupid people. We're goin to take back Pfizer, folks, and change it's corporate color from blue to green. That's right! No more Viagra girls running around in Pfizer blue. They're gonna wear green. And don't get me wrong, I love my girls in any color, but green is the color of money, and I'm goin to make Pfizer fabulously rich again. You're gonna be tired of being rich, and you won't even have to work for it. But the opioids will ruin you. I tell my children, you got a pain? Kick the asshole who gave it to you!!! That's my solution to the opioid problem. But you're gonna love it when I come back. Trust me, and don't forget to vote for me.

    Love,
    Donald
     
  9. anonymous

    anonymous Guest



    Trump is right about the risk of opioid withdrawal in opioid-experienced patients:

    Pfizer Inc. (NYSE: PFE) is awaiting FDA final action on its NDA for ALO-02 (oxycodone/naloxone). The FDA’s review has twice gone past it scheduled conclusion. ALO-02 uses the same approach as Embeda (morphine/naloxone). This approach already has demonstrated a risk of withdrawal if the sequestered opioid antagonist naloxone is accidentally released by chewing. Separately, the FDA is already concerned about a possible link between withdrawal and serious cardiovascular adverse events in opioid antagonists approved for treating opioid induced constipation. This potential risk does not exist for other FDA-approved, abuse-deterrent formulations of oxycodone (e.g., OxyContin OP and Xtampza) that rely on a physical/chemical approach.

    This is a major setback for the program, as the formulation does leak naltrexone. However, if Pfizer could argue that the naltrexone leakage is benefiting the patient in some way, then Pfizer could still win the day no matter what Trump says.
     
  10. anonymous

    anonymous Guest


    Tweet :D

    I don’t know who that idiot was, saying that Pfizer could win by arguing that naltrexone leakages is good for the patient, but I’m telling you now, there is no way Pfizer’s opioid is going to be approved. It’s a stupid concept, people! I mean, who would combine the antagonist with the agonist and feed it to unsuspecting patients who take it for legitimate pain. I mean – that’s nuts!!! All the druggie would need to do is put it in a hot cup a Joe and drink it without drinking the little beans it to get high, but if the beans releases naltrexone in normal use – that’s nuts! The druggie gets the high and the patient gets fucked by withdrawal. It’s not going to be like that when I’m president – BELIEVE YOU ME! – it’s not gonna be like that. I have big plans for Big Blue.

    For starters, we’re gonna rename the company Pfrump Towers Pharma, and then use Benghazi instead of Ireland as a tax shelter. I can make great deal with Benghazi. In fact, I’m gonna move the opioid program there and make Dr Limpwack my Ambassador to Benghazi. They're crazy about opioids there and Alan could even bring his sidekick on the opioid team - the little guy, the one that looks like a weasel - to serve as his interpreter. The little weasel guy would fit would fit right in with the extremists, so there would be no problem and no need for an Ad Com in the U.S. Pfizer – you’re just gonna love what I do for you when I’m elected president.

    :Donald
     
  11. anonymous

    anonymous Guest


    Seriously, are we prepared for the Pfizer ALO-02 Ad Com or not? My informants tell me we are not because of a reformulation issue. Another reformulation issue! Holy crap! Are we going to live through another Oxecta give back and Remoxy give back with ALO-02 and Embeda too? And what happened to ALO-04, the hydrocodone and naltrexone formulation. Did we Pfuck up that one too???
     
  12. anonymous

    anonymous Guest

    Heroin is so passè...all the Hep-Cats have moved onto perdeuteroPCP! It's a knockout!!
     
  13. anonymous

    anonymous Guest

    As a patient advocate for the treatment of chronic pain, I would trust that the Pfizer team could answer the following question at the Opioid Ad Com. As a non-abuser of opioids but taking CR oxycodone for chronic pain, why should I take ALO-02 if it has the potential to either lessen efficacy or cause withdrawal? And why should I pay more for it? How does the naltrexone in your product benefit the patient???
     
  14. anonymous

    anonymous Guest


    So, another question for the Ad Com to consider on June 8th would be:

    Should Troxyca ER be labeled as an opioid-withdrawal-inducing product when administered by the oral route of administration for chronic pain? Is that about it? Who wants to field this one? Donald Trump?
     
  15. anonymous

    anonymous Guest


    Interesting question. Another one would be, what good is naltrexone doing for the patient when Troxyca ER is so easily manipulated by the abuser? Probably none!
     
  16. anonymous

    anonymous Guest


    The FDA revealed at the Ad Com that “oxycodone can be extracted from Troxyca ER using multiple common solvents, some more easily than others.” Obviously the Advisory Committee agreed with that point of view today with their 9-6 vote against allowing a label claim that Troxyca ER has abuse deterrent properties when taken orally.

    Maybe we should go back to making meth!
     
  17. anonymous

    anonymous Guest

    The problem is with the hot melt extrusion process for combining the naltrexone and oxycodone/morphine. The naltrexone bead is damaged by the heat and pressure.
     
  18. anonymous

    anonymous Guest

    The advisory panel was unhappy with the requirements set by the FDA to get approval as an ADO. Some also had issues that there is a small window that takes hours when dissolved by an unnamed solvent to hack the naltrexone out. It's difficult to do and that is under lab conditions. Since your average abuser has no chance at hacking it, that's why they ultimately gave it a thumbs up.
     
  19. anonymous

    anonymous Guest

    http://www.painmedicinenews.com/Web-Only/Article/06-16/FDA-Advisory-Panels-Recommend-Approval-of-Troxyca-ER/36633/ses=ogst