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  • ARNA Management And Investors Underestimating The Potential Of Belviq And Phentermine Combination [View article]
    sharinky, Interesting points. Metformin is associated with weight loss and delaying type 2 diabetes in prediabetic patients. 2 for 1?
    Nov 13, 2014. 11:14 AM | Likes Like |Link to Comment
  • Bel-Phen Pilot Study News, Hold On To Your Shares [View article]
    Jonas500_,

    for clarity for other readers, ETRM (stock symbol) is developing vagal nerve stimulation requiring a laparoscopic procedure for obesity treatment.
    Nov 12, 2014. 03:58 PM | Likes Like |Link to Comment
  • Bel-Phen Pilot Study News, Hold On To Your Shares [View article]


    sbilhei,

    Have to look into Contrave, interesting point on substituting generics.

    Quick response on Qsymia, the doses of phentermine and topiramate are lower in Qsymia than the generic version pills, so it would be difficult to split the pills to achieve the proper dosing and the safety would be compromised if you just used generic two pill approach with higher doses.

    Interesting on black box warning. Suicidal ideation increase in patients suffering depression resulted in blackbox warnings on most antidepressant drugs. Psychiatrists are looking for ideation when starting therapy with antidepressants, but there is a difference in the incidence of ideation and suicide. There is evidence that the blackbox warnings decreased prescriptions for at least adolescent patients with depression, and controversial whether that is good or resulted in under treatment of depression. Not really ready to predict (guess) how it will affect prescriptions for patients being treated for obesity, although depression and obesity are often comorbid.

    Interesting point, anyone know if the actual Contrave clinical studies picked up an increase in suicidal ideation? This is a different patient population.

    From the Contrave label;
    "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND
    NEUROPSYCHIATRIC REACTIONS
    See full prescribing information for complete boxed warning
     Increased risk of suicidal thinking and behavior in
    children, adolescents, and young adults taking
    antidepressants for major depressive disorder and other
    psychiatric disorders. (5.1)
     Monitor for worsening and emergence of suicidal
    thoughts and behaviors. (5.1)
     Serious neuropsychiatric events have been reported in
    patients taking bupropion for smoking cessation. (5.2)
     CONTRAVE has not been studied in pediatric patients.
    (5.1)"
    Nov 11, 2014. 04:05 PM | 1 Like Like |Link to Comment
  • Bel-Phen Pilot Study News, Hold On To Your Shares [View article]

    Spencer,

    Interesting on the AF reports. A lot of drugs are associated with AF.

    http://bit.ly/1sy8Xvf

    Would the current trial pick up a difference in incidence of AF between placebo and Belviq?

    Do you think that is worrisome with regard to Arena valuation?
    Nov 11, 2014. 03:08 PM | Likes Like |Link to Comment
  • Bel-Phen Pilot Study News, Hold On To Your Shares [View article]
    SP500ChartCom

    Interesting point on drop out rates.

    Isn't efficacy the reverse order; Contrave - Qsymia - Belviq ?

    What es that foretell?
    Nov 11, 2014. 02:57 PM | Likes Like |Link to Comment
  • Bel-Phen Pilot Study News, Hold On To Your Shares [View article]
    Jim, and more so for other investors that may not have followed the initial approval of Lorcaserin, the FDA required a post-marketing safety trial for Lorcaserin with MACE as the primary outcome.

    http://bit.ly/MAt8bt

    From Arena; "As part of the approval of BELVIQ, the companies committed to conduct post-marketing studies to assess the safety and efficacy of BELVIQ for weight management in obese pediatric patients, as well as to evaluate the effect of long-term treatment with BELVIQ on the incidence of major adverse cardiovascular events in overweight and obese subjects with cardiovascular disease or multiple cardiovascular risk factors. The cardiovascular outcomes trial will include echocardiographic assessments."

    A trial is underway.

    http://1.usa.gov/1sy0Vm1

    from clinical trials.gov

    "Primary Outcome Measures:

    Time from randomization to first occurrence of Major Adverse Cardiovascular Events (MACE) [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    MACE events include: myocardial infarction, stroke and cardiovascular (CV) death

    Time from randomization to conversion to type 2 diabetes mellitus (T2DM) for subjects without any type of diabetes at Baseline [ Time Frame: Baseline, and specified timepoints up to 5 years ] [ Designated as safety issue: No ]
    Time from randomization to first occurrence of MACE+ [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    MACE+ events include: myocardial infarction, stroke, CV death, and hospitalization due to unstable angina, heart failure, or any coronary revascularization"

    I repeat, cardiovascular risk for Belviq (at a level low enough to make benefit outweigh adverse effect) remains unknown --- and the trial is underway.
    Nov 11, 2014. 02:39 PM | Likes Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    The small bel-Phen study / poster is in the article. A link to a photo of the poster of the small study of bel- Phen lacking any control groups ( no drug, bel, or Phen) is in the article for the reader's convenience and analysis. Emphasis seemed to be more on efficacy rather than safety in the study.
    Oct 2, 2014. 12:23 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    ? Tramadol is a μ-opioid receptor agonist amongst other activities, however pain relief is only partially antagonized by naloxone (and presumably naltrzone). It's schedule IV, not "non-addictive". Agree on the contraindication obviously. The labeling includes tramadol in patients should be opiod free before starting Contrave.
    Oct 1, 2014. 08:16 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Thx, but you shouldn't thank me for providing reinforcement, "all cause mortality", explain that concept to someone recovering from an MI.

    WOSCOPS and AFCAPS/TexCAPS show reductions in MI and other coronary events in the primary prevention (mostly) on reduction in non-fatal events. Not to mention the Jupiter study, as published showing reductions in events (which you say was "fudged" and others hold a similar view discounting the study because it was halted early and other reasons). Non fatal MIs are an important outcome with regard to statins.

    I can agree that Statin treatment should be stratified according to risk, but statins should not be excluded from primary prevention. The first link had some thoughts on CAC scans for risk stratification.

    The other point being glossed over is the Jupiter study was in patients with normal cholesterol levels, and high c reactive protein levels, which is affirmation in a large clinical study that stains have multiple mechanisms of action in reducing risk.
    Oct 1, 2014. 08:07 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    here's another supporting your view, since I never quite got the convoluted subtraction argument the first time around that makes non-fatal MIs of little importance. This one takes the all cause mortality approach.

    http://bit.ly/1wVUDB8

    and one that brings up the debate well

    http://bit.ly/1wVUDBb

    I think it would be more accurate to say the NNT is higher for primary prevention and the ratio of NNT to NNH needs to be considered more carefully for primary than secondary prevention. And that is why a tool used to measure risk needs to be correlated with outcomes, and the study we started this discussion on is important.

    Never?
    Sep 30, 2014. 08:00 PM | Likes Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Yes, the study shows that the new guidelines were a little better than the old in this patient population, which is a retrospective study of patient's getting angiograms. But meaningless? New vs old guidelines is a current controversial subject. And the last sentence excludes patients that don't meet the criteria for statin therapy.

    But that doesn't negate the prevailing view that statin benefit outweighs diabetes risk for primary prevention, of course according to risk which is why I mentioned guidelines, and definitely for secondary prevention.
    Sep 30, 2014. 05:45 PM | Likes Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Most conclude statin benefits outweigh diabetes risk. http://bit.ly/1nG7ZBC. New study shows the accuracy of matching statins to atherosclerotic burden with new guidelines are even better, I thnk very impressive. http://bit.ly/1nG7ZBE
    Sep 30, 2014. 01:50 PM | Likes Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Maybe he meant "advertise", interesting though, atypical antipyschotics are definitely advertised on TV as adjunct therapy, but phentermine is more the adjunct drug here. Would "marketing" the use of the combination be wise if the company decides to develop a patentable single formulation?
    Sep 30, 2014. 12:26 PM | Likes Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Yes, labeling change, thank you.

    You stated "If Eisai and Arena seek a labeling change, then the FDA may want another confirming study that does not have to be from a statistical standpoint any larger or longer than the current study."

    I doubt it. As you state "You don't know at all if the FDA will require another study". True enough, but for approval of a labeling change, it is a safe bet the FDA would require a larger trial. Future trials should be powered to rule out an increase in a low frequency of adverse events, I would speculate that MACE would be the primary outcome and valvulopathy as a secondary outcome just like CAMELLIA-TIMI. The current phentermine/belviq trial is 225 subjects in 3 arms. From clinicaltrials.gov, the current safety trial for Belviq (CAMELLIA-TIMI) with MACE as the primary outcome is recruiting "Approximately 12,000 subjects will be randomized to two treatment groups in a ratio of 1:1".

    That's a 50 fold difference!

    But on the flip side and in support of your position, the safety hurdle for approval of obesity drugs regarding cardiovascular risk was lower than the hurdle for current new diabetes drugs, at least for Arena and Vivus, not as much so for Orexigen.
    Sep 30, 2014. 12:22 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Nothing to do with investing, but in the prescribing information, it states that patients may be more responsive to opiates immediately after stopping Contrave (presumably to take opiate pain meds), so lower opiate doses may be appropriate.
    Sep 29, 2014. 11:55 AM | Likes Like |Link to Comment
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