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    DGAP-Adhoc  1387  0 Kommentare PAION REPORTS POSITIVE REMIMAZOLAM HEADLINE DATA IN PIVOTAL U.S. PHASE III STUDY IN PROCEDURAL SEDATION FOR COLONOSCOPY


    PAION AG / Key word(s): Research Update

    19.06.2016 17:44

    Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
    by DGAP - a service of EQS Group AG.
    The issuer is solely responsible for the content of this announcement.

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    PAION REPORTS POSITIVE REMIMAZOLAM HEADLINE DATA IN PIVOTAL U.S. PHASE III
    STUDY IN PROCEDURAL SEDATION FOR COLONOSCOPY

    - Primary efficacy outcome measure successfully achieved

    - Consistent safety profile with that observed in previous studies

    - Conference Call on remimazolam headline data on Monday, 20 June 2016

    Aachen (Germany), 19 June 2016 - The Specialty Pharma Company PAION AG
    (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today
    announced that remimazolam, its ultra-short-acting benzodiazepine sedative/
    anesthetic, met its primary efficacy endpoint in the first study of its
    pivotal U.S. Phase III program in patients undergoing procedural sedation.

    The study enrolled a total of 461 patients at 13 U.S. sites and was
    designed to evaluate the efficacy and safety of remimazolam compared to
    placebo (with midazolam rescue) in patients undergoing proceduralist-
    administered sedation for colonoscopy. The primary outcome measure, success
    of the procedure, was reached in 91.3% of the patients in the remimazolam
    arm and in 5.0% in the placebo (including midazolam rescue) arm. The safety
    profile of remimazolam was consistent with that observed in previous
    studies.

    In important secondary endpoints, the remimazolam arm showed a mean time to
    start of procedure of 5.1 minutes and a mean time from end of procedure to
    return to full alertness of the patients of 9.25 minutes. Evaluation of the
    full data set is ongoing and will be presented in an appropriate
    scientific, peer-reviewed format at a later date.

    This study also included an open label arm in which midazolam was dosed
    according to U.S. label. The data resulting from this non-comparative arm
    may be useful for hypothesis generation for future research and pharmaco-
    economic modelling.

    Although the study designs are not identical, the Phase III study results
    were in line with findings from a previous U.S. Phase IIb double-blind
    randomized comparative study between remimazolam and midazolam in 162
    patients undergoing routine colonoscopy, where patients in the remimazolam
    arm showed significantly enhanced colonoscopy success rates and shorter
    times to start of procedure, shorter times from end of procedure to return
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    DGAP-Adhoc PAION REPORTS POSITIVE REMIMAZOLAM HEADLINE DATA IN PIVOTAL U.S. PHASE III STUDY IN PROCEDURAL SEDATION FOR COLONOSCOPY PAION AG / Key word(s): Research Update 19.06.2016 17:44 Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. …