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
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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
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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