Movantik

Discussion in 'Ironwood Pharmaceuticals' started by Anonymous, Aug 26, 2014 at 11:13 PM.

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  1. Anonymous

    Anonymous Guest

    Less than a month away and your new competitor will be approved, except it will have the OIC indication and your drug won't. Expect insurance plans to start denying Linzess in favor of Movantik. Eventually, this will spill over into your CIC and IBS business. Good luck playing against AZ, Suckas!
     

  2. Anonymous

    Anonymous Guest

    Yeah only it's not approved for ibs or cic, lol. Insurance companies won't cover it. 89% of commercial plans cover linzess. Okc studies underway in next year for linzess we will have all three indications 'sucka' sorry you didn't get the job
     
  3. Anonymous

    Anonymous Guest

    *oic
     
  4. Anonymous

    Anonymous Guest

    It is true that OIC studies are underway. They wont finish until next year. Earliest that indication can be filed is Q3 2015 - Indication can't be approved any earlier than 2016.
     
  5. Anonymous

    Anonymous Guest

    You miss the point. Docs write Linzess over Amitiza for OIC despite having indication. Movantik will be perceived as more powerful and docs will write it for CIC and IBS despite the indication. Did I mention the AZ machine will be selling it? Got it, buttercup?
     
  6. Anonymous

    Anonymous Guest

    dream on LOL. Movantik (naloxegol) is a peripherally-acting mu-opioid receptor antagonist. good luck selling the safety profile of that against a natural amino acid peptide with zero safety issues...especially since the whole class of mu-opioid receptor antagonists has potential cardiac safety issues. risk/reward ratio here ???
     
  7. Anonymous

    Anonymous Guest

    Irrelevant. You're missing the biggest point of all.

    quote: "..."So, the focus that starts to surface is the possibility of whether or not withdrawal or low-grade withdrawal might actually lead to a cardiovascular event," said Salix R&D chief Bill Forbes, further explaining FDA's safety concerns to analysts and investors on a conference call.

    "In order to understand this potential risk, the Division [FDA] has communicated that a very large, well-controlled, chronic administration trial will have to be conducted to assess the safety of any mu-opioid antagonist prior to market approval for the treatment of patients with OIC who are taking opioids for chronic, non-cancer pain," Salix said. "

    http://www.thestreet.com/story/11763306/1/fda-places-new-heart-safety-hurdle-in-path-of-opioid-constipation-drugs.html

    even in the recent FDA advisory panel discussion meeting, there was still considerable doubt about whether or not there may be a class effect & whether large scale safety trials under chronic use conditions are warranted:

    (quote) "...In their vote on this issue, most committee members agreed that such outcome trials aren't warranted. They felt that with the exception of alvimopan, cardiovascular safety going forward can be assessed postmarket, but that these trials should be at least 1 year in length to assess long-term outcomes."

    http://www.medscape.com/viewarticle/826704#2

    In other words, even if Movantik should get approved (PDUFA date next month), the post-marketing commitment would be expected to include a potentially longer term cardiovascular safety monitoring commitment.

    That's medical liability lawyers "bread&butter" stuff, especially in view of the GSK014 study (alvimopan, same class). Some of the committee members even called the cardiac safety signal discovered in that study a "canary in a coal mine".

    So - on which planet would anyone want to prescribe a mu-opioid receptor antagonist, if a highly potent peptide drug without systemic exposure (and no cardiovascular safety issue) is available for the same indication ??

    In my humble opinion, if and when linaclotide will get approved for OIC (maybe even before that, due to off-label use ?), NONE of the mu-opioid receptor antagonists (incl. Movantik) has a prayer.
     
  8. Anonymous

    Anonymous Guest

    You should ask this question on the Forest boards, they are the ones running the show with Linzess. They have the FSR1 reps, which are the GI specialty reps and they would have a better insight into the GI market than Ironwood reps.
     
  9. Anonymous

    Anonymous Guest

    I sold an MU opioid receptor A and it was a disaster .. Nobody would touch it and no hospitals wanted any part of it because of the black box warning and the poor clinical data.. Gi motility would improve maybe a day sooner than walking and chewing gum.. Complete waste of money for hospitals
     
  10. Anonymous

    Anonymous Guest

    Expect this is an oral, not MU opiod receptor A. The oral MU will rule the market, patients are having BM's within 1 hour of taking this drug.
     
  11. Anonymous

    Anonymous Guest

    71% of linzess patients have vm in first 24 hours, not exactly lagging in speed. Docs aren't going to be able to write it off label due to it not being covered by insurance companies. Pretty sure a patient isn't going to be cool with being diagnosed as addicted to opioids lol
     
  12. Anonymous

    Anonymous Guest

    Re: Movantik / post marketing commitment

    what did I tell you ? exactly as expected: approved today, but with a substantial cardiovascular monitoring post marketing commitment, see :

    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm414620.htm