PAION AG
PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN U.S. PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY
DGAP-News: 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. “We would like to thank all patients and staff of the participating sites”, Dr. Wolfgang Söhngen, PAION AG’s CEO, commented. “We are pleased to have been able to significantly speed up patient recruitment and to successfully complete the study. We will now consolidate the data base and finalize all outstanding work related to the study. This will allow us to report headline data mid 2017. Thanks also to all PAIONeers who worked very hard to meet an important deadline.” ### In clinical studies, remimazolam demonstrated efficacy and safety in far over 1,000 patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile. Remimazolam is currently in clinical Phase III development for procedural sedation in the U.S. After completion of the ongoing development, the implementation of a pediatric development plan already agreed with the FDA is planned. A full clinical development program for general anesthesia was completed in Japan, and a Phase II study in general anesthesia was completed in the EU. Based on the positive results of a Phase II study, development for ICU sedation beyond 24 hours is another attractive indication. PAION’s vision is to become an acknowledged “PAIONeer” in sedation and anesthesia. 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.
28.03.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |
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 News | DGAP News Service |