DGAP-News

PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN U.S. PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY - Seite 2

The randomized open-label midazolam study arm was added to generate data based on the labelled midazolam dose (U.S. label), including onset/offset times. It also served as an additional safety reference.

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."

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About remimazolam

Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation and anesthesia if necessary.

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.


Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey, the MENA region, and South Korea with Cosmo, Pharmascience (Pendopharm), Yichang Humanwell, R-Pharm, TR-Pharm, and Hana Pharm, respectively. For all other markets, remimazolam is available for licensing.