PAION AG: FDA CONSIDERS CURRENT HUMAN ABUSE LIABILITY PROGRAM WITH REMIMAZOLAM IN THE U.S. AS SUFFICIENT; NO SECOND INTRANASAL STUDY REQUIRED
FDA CONSIDERS CURRENT HUMAN ABUSE LIABILITY PROGRAM WITH REMIMAZOLAM IN THE U.S. AS SUFFICIENT; NO SECOND INTRANASAL STUDY REQUIRED
- The FDA has determined that the available studies are sufficient to provide necessary data regarding the abuse potential of remimazolam in humans
- No second intranasal study required
- PAION assumes clinical development program for remimazolam in procedural sedation in the U.S. as completed
Aachen (Germany), 14 November 2017 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today announces that the FDA informed PAION last night that no additional study is required based on the submitted data. The FDA further informed PAION that it determines the abuse liability program conducted by PAION as sufficient to provide the necessary data regarding the abuse potential of remimazolam in humans. PAION therefore assumes the clinical development program for remimazolam in procedural sedation in the U.S. as completed and will now focus on finishing the respective reports.
The results of the abuse liability program will be part of the New Drug Application (NDA) for remimazolam in procedural sedation in the U.S., which partner Cosmo Pharmaceuticals currently expects to submit in the second half of 2018.
Based on the results of preclinical and Phase I studies and in consultation with the FDA, PAION had initiated additional Phase I studies to further assess the abuse potential of remimazolam. Two aspects were studied: if remimazolam could inappropriately be used as a knock-out cocktail in combination with alcohol and if it could be abused intranasally. Recruitment of a trial evaluating the oral administration of remimazolam with alcohol was completed in the third quarter of 2017. Recruitment of the first trial evaluating the intranasal administration of remimazolam was completed in the second quarter of 2017.End of inside information
Contact Ralf Penner Vice President Relations/Public Relations Martinstrasse 10-12 52062 Aachen - Germany Phone +49 241 4453-152 E-mail firstname.lastname@example.org www.paion.com
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.
14-Nov-2017 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.deLanguage: English Company: PAION AG Martinstr. 10-12 52062 Aachen
Germany Phone: +49 (0)241-4453-0 Fax: +49 (0)241-4453-100 E-mail: email@example.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
628789 14-Nov-2017 CET/CEST