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Insmed Incorporated Message Board

  • fudfighter4 fudfighter4 Jul 12, 2013 10:40 AM Flag

    Arikace was proved safer than Tobi at Phase III

    Number of subjects with treatment-emergent adverse events by seriousness -

    1. Serious

    Arikace: 26 out of 148
    Tobi: 29 out of 146

    2. Not serious

    Arikace: 125 out of 148
    Tobi: 113 out of 146

    3. Life Threatening or Disabling

    Arikace: 0 out of 148
    Tobi: 1 out of 146

    Arikace will not only be far safer than the antibiotics presently used by the Cystic Fibrosis population (the liposomal delivery prevents all but a negligible amount of the antibiotic from reaching the bloodstream) - it will be the only antibiotic capable of delivering a noticeable improvement in lung function with prolonged use - and the only inhaled antibiotic requiring administration just once daily.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Bonnie Ramsey, MD

      Seattle Children's Hospital, Director, Cystic Fibrosis Therapeutics, Development Network Coordinating Center and Chair of the study Steering Committee

      Right. So on Steering Committee, we have looked at the adverse event profile compared with the comparator, which is TOBI and none of them were unexpected. This is a patient population that tends to have respiratory symptoms of all kinds. And therefore, it's not unexpected to have a certain level of symptoms such as cough and so the distribution actually looked very comparable between the two.

      There was one patient, who had two episodes of severe hemoptysis and that patient actually was in the TOBI arm. So there was no patient in the ARIKACE arm with severe hemoptysis, which might have been a concern.

      Canaccord Genuity

      Thanks. That actually links directly to my follow up, which is any of the severe side effects that you have seen on either ototox or kidney tox?

      Renu Gupta

      I can take that question. There is no evidence of renal toxicity and there is no evidence of ototoxicity attributed to either study.

      Comparison of drop-out rates:

      TIP vs TIS -

      27% TIS - 18% TIP

      Arikace vs TIS -

      10% overall.

    • As regards efficacy - the FDA decided to approve Tobramycin Inhalation Powder despite the fact that it failed in one of its Phase III studies to demonstrate superior efficacy to a PLACEBO.

      27% of the TIP arm dropped out during the study, and agency staff publicly voiced concerns over both safety and efficacy.

      But even though TIP needs to be administered twice-daily it still takes around one-quarter of the time of the inhalation solution. The FDA clearly has a high priority of countering the threat of antimicrobial resistance by promoting better compliance. Once-daily Arikace imo will be a no-brainer for the FDA.

      TIP % vs TIS %

      48.40 ... 31.10 ... Cough
      33.80 ... 30.10 ... Lung disorder / exacerbation
      18.20 ... 19.60 ... Productive cough
      15.60 ... 12.40 ... Dyspnea
      15.60 ... 12.40 ... Pyrexia
      14.00 ... 10.50 ... Oropharyngeal pain
      13.60 ... 03.80 ... Dysphonia
      13.00 ... 12.40 ... Hemoptysis
      11.40 ... 12.00 ... Headache
      08.10 ... 07.20 ... Nasal congestion
      07.50 ... 09.60 ... Nausea
      07.10 ... 06.20 ... Rales
      06.80 ... 06.20 ... Wheezing
      06.50 ... 02.90 ... Chest discomfort
      06.20 ... 05.70 ... Vomiting
      04.50 ... 01.90 ... Throat irritation
      04.20 ... 01.90 ... Diarrhea
      03.90 ... 00.50 ... Dysgeusia
      02.60 ... 01.90 ... Epistaxis
      02.30 ... 02.40 ... Rash
      01.60 ... 00.50 ... Bronchospasm

      01.90 ... 02.40 ... Tinnitus
      01.00 ... 00.50 ... Hearing loss

      03.90 ... 01.00 ... FEV-1 deterioration

      27.00 ... 18.00 ... Discontinuation

    • When the news is grave
      And you can't be saved
      Who ya gonna call
      TURDPUMPERS

      Fuddy please stop posting lies....

 
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