Seeking Alpha
View as an RSS Feed

Rx Stocks  

View Rx Stocks' Comments BY TICKER:
Latest  |  Highest rated
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Yes, I meant to say thanks, Rod27. thank you healthythoughts.

    worth considering, there is likely overlap in patient populations requiring chronic pain relief and candidates for obesity drugs, but how much?
    Sep 29, 2014. 11:21 AM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Nice examples, overly restrictive labeling (liver function testing), which created the perception that these drugs may not have an excellent safety profile, may well have slowed the implementation of the most effective class of drugs for reducing risk from atherosclerosis. But Baycol (Cerivastatin) use, many cases involving co-administration with gemfibrozil, is attributed with 52 deaths. Caution on combination use, in retrospect, was warranted for fibrates, but probably not so much for Niacin. Niacin efficacy, well that became controversial recently as you note. Your comment "So go with the best information you have, make your best choice, and be prepared to change." addresses Niacin well indeed.

    Your approach to informed consent, more when risk is unknown or greater, is commendable. You wrote "There's always informed consent. This is true with any medication. A little more informed consent for sure when you're waiting on the safety study on B+P. A discussion of risk and benefits always required. "

    But clinical trials require informed consent in a fashion meeting standards and approved by an Institutional Review Board (IRB) for the explicit protection of human subjects. Prescribing drugs, informed consent is up to the prescribing physician, nurse practitioner, or Physician's assistant.

    Prospective clinical trials are less likely to result in economically devastating lawsuits like other serious drug safety problems picked up in other ways.
    Sep 28, 2014. 06:43 PM | Likes Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Yes, drugs are used in combination without adequate evidence (trials). But, for large markets, trials are sometimes done to increase labeling indications. For example, use of diabetes drugs in combination (http://prn.to/1rmwhRR).

    "B+P" is in the first pilot trial, and the potential, if warranted, could be formulate it as a single patentable drug.

    Safety of different dosages is important, especially with Phentermine. Qsymia is difficult to replace by prescribing Topiramate and Phentermine independently. Safety could be an issue. The single formulation reduces the dose of both drugs from the previous indications for epilepsy or obesity. The "B+P" trial is investigating two dosages of Phentermine.
    Sep 28, 2014. 06:01 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    not "will", but is contraindicated, from the prescribing info " CONTRAVE is contraindicated in ...
    Chronic opioid or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use, or acute opiate withdrawal [see Warnings and Precautions (5.4) and Drug Interactions (7.2)] "

    But, will this impact sales? What portion of the potential market for Contrave are patients being treated with opiates? Albeit, Contrave ia an opioid antagonist, but are Lorcaserin or Qsymia appropriate for these patients?
    Sep 28, 2014. 05:38 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Yes, there are four secondary outcomes involving weight, BMI, etc., primary outcome is serotonergic adverse effects. Also, the trial is not recruiting patients, so presumably the patients have been enrolled and the trial is only 12 weeks, but I could not find a press release on when they will report anything. I suggest keeping in mind this is termed a pilot study, three arms of 75 patients so other studies will be required before submitting to the FDA for a new indication. Admittedly, any safety ( and efficacy) data could impact premature prescription of Bel-Phen. Speculation on ARNA share valuation because of Bel-Phen is fine, the article points out that premature prescribing may present an Investment risk because a safety signal may be picked up outside of a trial. Spencer's points on smoking cessation, also " just starting" are appropriate for speculation.
    Sep 28, 2014. 02:59 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    I think my point, relevant to investors, is that picking up safety problems outside of clinical trials has investment risk. Baycol, a statin, was withdrawn because of Rhabdomyolysis. To some extent, it was because Baycol was used in combination with Gemfibrozil. The risk is higher with Baycol than others, although it is a risk with all statins. Thank you, the clarity may not have come through on that point.
    Sep 28, 2014. 01:43 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Correction submitted, however the effect of the two in combination remains unknown, however the link to the poster is included. Small study, lacking peer review, but interesting and relevant to the discussion. Thank you.
    Sep 28, 2014. 01:31 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    correction submitted, Thank you
    Sep 28, 2014. 01:27 PM | 2 Likes Like |Link to Comment
  • Ruger Innovation Continues, But You Can't Beat The Cycle [View article]
    Useful info, AR's are being discounted, how are Ruger's SR 556 / 762 doing?
    Sep 25, 2014. 11:04 PM | Likes Like |Link to Comment
  • It Takes Less Than 15 Minutes To Buy VVUS Shares! [View article]
    good catch Al, unrelated to ED treatment, Consolidated Edison, Inc. (ED) is a stable dividend paying utility stock.
    Sep 19, 2014. 12:37 PM | 1 Like Like |Link to Comment
  • It Takes Less Than 15 Minutes To Buy VVUS Shares! [View article]
    Thx, correction submitted. Good point on alcohol.
    Sep 19, 2014. 09:36 AM | 1 Like Like |Link to Comment
  • Why You Should Sell Vertex [View article]
    Nice point on genotypes, treatment succes has varied according to genotype, Thx

    From Gilead, phase 3 underway on genotype 1 and combination therapy.

    http://bit.ly/129vUfW

    Advancing a Fixed-Dose Combination Tablet for HCV

    Gilead is currently evaluating a once-daily fixed-dose combination tablet containing sofosbuvir and GS-5885 in several Phase 2 and 3 trials. The studies evaluate sofosbuvir/GS-5885 with and without RBV among a range of genotype 1 HCV patient populations.

    ION-1: This Phase 3 trial was initiated in October 2012 and is evaluating sofosbuvir/GS-5885 with and without RBV for 12 or 24 weeks among treatment-naïve genotype 1 patients. Pending a review of results from the two 12-week arms (n=50/arm) of an initial enrollment of 200 patients, ION-1 will continue to recruit patients and assess sofosbuvir/GS-5885 in a total of 800 individuals.
    ION-2: Gilead today announced that a second Phase 3 study for sofosbuvir/GS-5885, ION-2, is expected to begin screening patients in January 2013. This study will evaluate the fixed-dose combination, with RBV for 12 weeks and with and without RBV for 24 weeks of therapy among 400 treatment-experienced genotype 1 HCV patients. Participants in this study will have failed past therapy with regimens containing IFN or IFN plus a protease inhibitor.
    LONESTAR: Gilead also announced that enrollment is now underway for a new Phase 2 study of sofosbuvir/GS-5885 for 12 weeks and of sofosbuvir/GS-5885 with and without RBV for 8 weeks among genotype 1 treatment-naïve patients. Two additional arms in this trial will evaluate sofosbuvir/GS-5885 with and without RBV for 12 weeks among treatment-experienced genotype 1 patients who had previously received a protease inhibitor-containing regimen. This study, which will enroll 100 patients, is the first trial to evaluate the combination of sofosbuvir and
    GS-5885 for only eight weeks of treatment.
    Jan 30, 2013. 10:09 AM | Likes Like |Link to Comment
  • Why You Should Sell Vertex [View article]
    From FDA news release
    http://1.usa.gov/VMEVqV
    "CF, which affects about 30,000 people in the United States, is the most common fatal genetic disease in the Caucasian population. About 4 percent of those with CF, or roughly 1,200 people, are believed to have the G551D mutation."

    Some will be covered by insurance and, to Vertex' credit, Vertex will provide the drug for uninsured patients with household income less than 150K.

    from http://bit.ly/WRRvSv

    "The 1983 Orphan Drug Act allows FDA to offer drug companies incentives including fast-track review and market exclusivity for several years after approval. In addition, the CF Foundation has invested $75 million in the Vertex CF drug program. Nevertheless, Kalydeco will be an expensive medication, with a current annual estimate of $294,000 per patient. Analysts forecast a potential $500 million in annual sales for Vertex. The company announced it would provide the drug free of charge for households with a yearly income of $150,000 or less. For the others, Vertex would cover up to 30% of the drug’s list price. "
    Jan 21, 2013. 06:03 PM | Likes Like |Link to Comment
  • Why You Should Sell Vertex [View article]
    The current drug targets G551D mutation in CFTR, the drug under development targets the F508 CFTR mutant allele. Important drug, but there are 30,000 CF patients in the US and
    from http://bit.ly/Vl70o0
    "The researchers explain that Kalydeco only works in patients with the G551D mutation, and does not work in the most common form of CF, which occurs in patients who have two copies of the F508 mutation in the CFTR gene. They say that an FDA approved test should be taken before patients with CF take Kalydeco, if their mutation status is unknown. "
    Jan 21, 2013. 05:31 PM | Likes Like |Link to Comment
  • Arena: A Share Price Model [View article]
    http://seekingalpha.co...
    Jan 21, 2013. 04:31 PM | Likes Like |Link to Comment
COMMENTS STATS
125 Comments
31 Likes