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PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY - Seite 2
into the overall efficacy and safety data sets for the FDA filing process."
Dr. Johannes Blatter, PAION's CMO, commented: "We are extremely satisfied
with the course of the study. The inclusion and treatment of 460 patients
was carried out very efficiently. I would like to give a special thanks to
the internal and external teams, which have ensured a high quality study
with their tireless efforts, enthusiasm and care."
###
About Remimazolam
Remimazolam is an ultra-short-acting intravenous sedative and anesthetic,
currently in Phase III clinical development for procedural sedation and
general anesthesia. Remimazolam is a member of the class of substances
known as benzodiazepines. 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 in order to
rapidly terminate sedation if necessary.
In clinical studies, Remimazolam demonstrated efficacy and safety in far
more than 1,000 patients. A confirmatory Phase III program is currently in
progress in procedural sedation. Data so far indicate that Remimazolam has
the expected rapid onset and offset of action combined with a favorable
hemodynamic stability profile.
In the U.S., Remimazolam is currently being developed for procedural
sedation during procedures such as colonoscopies.
In the EU and most other major markets, Remimazolam is initially being
developed for general anesthesia, including post-operative sedation in
post-anesthesia care or intensive care units (ICUs) for up to 24 hours
after the operation.
In Japan, a clinical Phase III program in general anesthesia has been
successfully completed.
Development for ICU sedation beyond 24 hours is planned following
successful completion of development in procedural sedation and general
anesthesia. A pediatric development plan has been agreed with the FDA and
will be implemented following development of Remimazolam for adult
patients.
Remimazolam is available for licensing outside China, Russia (CIS), Turkey,
the MENA region, South Korea and Canada, where the compound is partnered
with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm,
respectively. In the U.S. and EU, PAION focuses on the attractive
opportunity of an own commercialization or co-commercialization.
About PAION
PAION AG is a publicly listed Specialty Pharmaceutical Company
headquartered in Aachen (Germany) with operations in Cambridge (United
Kingdom) and New Jersey (USA). PAION's lead substance, Remimazolam, is an
intravenous ultra-short-acting anesthetic in Phase III clinical development
Remimazolam is an ultra-short-acting intravenous sedative and anesthetic,
currently in Phase III clinical development for procedural sedation and
general anesthesia. Remimazolam is a member of the class of substances
known as benzodiazepines. 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 in order to
rapidly terminate sedation if necessary.
In clinical studies, Remimazolam demonstrated efficacy and safety in far
more than 1,000 patients. A confirmatory Phase III program is currently in
progress in procedural sedation. Data so far indicate that Remimazolam has
the expected rapid onset and offset of action combined with a favorable
hemodynamic stability profile.
In the U.S., Remimazolam is currently being developed for procedural
sedation during procedures such as colonoscopies.
In the EU and most other major markets, Remimazolam is initially being
developed for general anesthesia, including post-operative sedation in
post-anesthesia care or intensive care units (ICUs) for up to 24 hours
after the operation.
In Japan, a clinical Phase III program in general anesthesia has been
successfully completed.
Development for ICU sedation beyond 24 hours is planned following
successful completion of development in procedural sedation and general
anesthesia. A pediatric development plan has been agreed with the FDA and
will be implemented following development of Remimazolam for adult
patients.
Remimazolam is available for licensing outside China, Russia (CIS), Turkey,
the MENA region, South Korea and Canada, where the compound is partnered
with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm,
respectively. In the U.S. and EU, PAION focuses on the attractive
opportunity of an own commercialization or co-commercialization.
About PAION
PAION AG is a publicly listed Specialty Pharmaceutical Company
headquartered in Aachen (Germany) with operations in Cambridge (United
Kingdom) and New Jersey (USA). PAION's lead substance, Remimazolam, is an
intravenous ultra-short-acting anesthetic in Phase III clinical development
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