PAION AG
PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN U.S. PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY
PAION AG / Key word(s): Research Update PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN U.S. PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY – Headline data expected mid 2017
The trial is the second pivotal study of the remimazolam Phase III program which was agreed upon between PAION and the U.S. Food and Drug Administration (FDA) for the filing of remimazolam for market approval in the targeted indication procedural sedation. This Phase III clinical trial – conducted at multiple sites throughout the U.S. – is a prospective, double-blind, randomized, midazolam- and placebo-controlled study in 446 patients undergoing bronchoscopy for diagnostic or therapeutic reasons. Patients were randomized to receive either remimazolam, midazolam, or placebo in addition to fentanyl, in order to achieve adequate sedation to start and perform the procedure. The primary efficacy endpoint is the successful completion of the bronchoscopy procedure with no requirement for an alternative sedative. In order to ensure the performance of the scheduled bronchoscopy for all patients regardless of their randomized treatment assignment, non-responders in all treatment arms received midazolam doses according to the physician’s discretion. Headline data are expected mid 2017. End of inside information PAION Contact Disclaimer: This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG’s management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company’s assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.
27-March-2017 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
Language: | English |
Company: | PAION AG |
Martinstr. 10-12 | |
52062 Aachen | |
Germany | |
Phone: | +49 (0)241-4453-0 |
Fax: | +49 (0)241-4453-100 |
E-mail: | info@paion.com |
Internet: | www.paion.com |
ISIN: | DE000A0B65S3 |
WKN: | A0B65S |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange |
End of Announcement | DGAP News Service |