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DGAP-News: PAION AG / Key word(s): Research Update
PAION CLOSES ENROLLMENT IN EU PHASE III TRIAL WITH REMIMAZOLAM IN GENERAL ANESTHESIA
- 424 patients have been enrolled representing a sufficient number to conduct the planned statistical analyses
- Data monitoring committee has agreed to close the trial with the current number of patients
- Topline study results expected in H2 2020, timeline for MAA submission confirmed
Aachen (Germany), 02 April 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces the close of patient recruitment in the EU Phase III trial with remimazolam, an ultra-short-acting benzodiazepine sedative/anesthetic, for the induction and maintenance of general anesthesia.
The randomized, single-blind, propofol-controlled, confirmatory Phase III trial was expected to enroll approximately 500 ASA III/IV patients (American Society of Anesthesiologists classification III to IV) undergoing planned surgery at more than 20 European sites. Due to the coronavirus pandemic, patient recruitment was completed at 424 patients agreed to by the Data Monitoring Committee.
PAION believes that these data will provide sufficient statistical power to conduct analyses of the primary and secondary endpoints of the trial. Data from Phase III trials conducted by our licensees in South Korea and Russia will provide additional safety data in the general anesthesia indication.
Topline data are expected in the second half of 2020 and the timeline for preparing regulatory submission following the anticipated approval of remimazolam in procedural sedation in the EU remains unchanged.
The primary objective of the trial is to demonstrate the non-inferiority of remimazolam compared to propofol for the induction and maintenance of general anesthesia during elective surgery. The key secondary objective is to show improved hemodynamic stability (avoidance of intraoperative drop of blood pressure and vasopressor usage) compared to propofol.
Based on Scientific Advice obtained from the European Medicines Agency (EMA) in January 2018, PAION expects that a positive Phase III trial in combination with previously completed clinical studies in Europe, South Korea, Russia and Japan should be sufficient for market approval in the indication of general anesthesia in the EU.
Assuming approval of the Marketing Authorization Application (MAA) in procedural sedation and positive results in this Phase III trial in general anesthesia, PAION plans to submit an extension of the marketing authorization application for remimazolam for general anesthesia. The review process for an extension is generally faster than for an MAA. The complete data from the EU Phase III study in general anesthesia, which are required for the submission of an extension of marketing authorization application, are expected to be available at the time of the regulatory decision on the MAA in procedural sedation. PAION is allowed to submit an extension for general anesthesia after the EMA's decision on the MAA in procedural sedation at the earliest.
Dr. Jim Phillips, CEO of PAION AG, commented: "Following discussion with the Data Monitoring Committee and a careful assessment of the current situation, given the ongoing coronavirus pandemic, we believe it is the right decision to stop recruitment in the remimazolam Phase III trial in general anesthesia now.
The statistical powering of the study means that we are confident that we can report both primary and secondary endpoints in the analysis. We look forward to obtaining topline data in the second half of 2020 and, if all goes as expected, preparing for a regulatory submission following the anticipated approval of remimazolam in procedural sedation in the EU.
We would like to thank all of the hospitals participating in the Phase III study for their work with our trial and we give thanks to all our healthcare colleagues & centres for their work now to combat the Covid-19 pandemic."
In Japan, licensee Mundipharma received market approval in general anesthesia in January 2020. In the U.S., licensee Cosmo Pharmaceuticals submitted a New Drug Application for procedural sedation in April 2019, with a PDUFA decision date of 05 July 2020. In China, licensee Yichang Humanwell filed for market approval in procedural sedation in November 2018. In South Korea, licensee Hana Pharm filed for market approval in general anesthesia in December 2019. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019 and results of an EU Phase III trial in general anesthesia are expected in the second half of 2020.
In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
Remimazolam is partnered in the U.S. (Cosmo Pharmaceuticals, sublicensed to Acacia Pharma), Japan (Mundipharma), China (Yichang Humanwell), Canada (Pharmascience), Russia/CIS, Turkey and the MENA region
In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. Results of a Phase III trial in general anesthesia are expected in the second half of 2020.
PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia & critical care by bringing novel products to market to benefit patients, doctors & stakeholders in healthcare.
PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
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