PAION AG
PAION AG: FDA CONSIDERS CURRENT HUMAN ABUSE LIABILITY PROGRAM WITH REMIMAZOLAM IN THE U.S. AS SUFFICIENT; NO SECOND INTRANASAL STUDY REQUIRED
PAION AG / Key word(s): Research Update 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. ### Contact Disclaimer:
14-Nov-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 |
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