MAHWAH, NJ, USA I June 8, 2015 I PAION, Inc., a wholly owned subsidiary of PAION AG, today announced the initiation of the second pivotal U.S. Phase 3 clinical trial of Remimazolam, an ultra-short-acting sedative/anesthetic, for procedural sedation in patients undergoing bronchoscopy.
The current trial forms the second pivotal study of the Remimazolam Phase 3 program. PAION and the U.S. Food and Drug Administration (FDA) have agreed on the remaining development program (indications, size of studies and design).
Greg Papaz, president and chief executive officer of PAION, Inc., said: “The Phase 3 bronchoscopy study is intended to confirm the efficacy and safety profile of Remimazolam in additional procedural sedation applications with the intention of broadening the target patient population and to achieve a broad label in procedural sedation. Because most patients undergoing bronchoscopy have a pre-existing pulmonary disease, Remimazolam’s benign safety profile including its effect on the respiration system is critically important to its success as a sedative for these procedures. During Phase 2 clinical trials in colonoscopy and upper endoscopy, Remimazolam had an excellent safety profile including respiratory stability and was highly effective in providing sedation resulting in successfully completed procedures.”
This Phase 3 clinical trial is a prospective, double-blind, randomized, placebo- and midazolam-controlled, U.S. multicenter study in 460 patients undergoing bronchoscopies. Patients will be randomized to receive Remimazolam, midazolam or placebo in addition to fentanyl to achieve moderate sedation. The primary endpoint is the successful completion of the bronchoscopy procedure with no requirement for an alternative sedative. The completion of patient recruitment is expected in 2016.
About Remimazolam
Remimazolam is an innovative ultra-short-acting general sedative/anesthetic. As a result of its short duration of action and good controllability, it has a preferable efficacy and safety profile relative to other currently marketed anesthesia compounds. Remimazolam’s rapid offset is a consequence of its metabolism by tissue esterase enzymes that are widely distributed throughout the body. While the key positioning in conscious sedation will be a low impact on respiratory function it will be cardiovascular stability for general anesthesia. Remimazolam has potential in three indications:
- Procedural sedation (Lead indication U.S.)
- General anesthesia (Lead indication EU, Japan)
- ICU sedation (Phase 2 Japan)
Remimazolam is available for licensing outside China, Russia (CIS) Turkey, MENA Region, South Korea and Canada, where the compound is partnered with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm.
About PAION
PAION AG is a publicly-listed Specialty Pharma Company headquartered in Aachen, Germany with further sites in Cambridge, UK and New Jersey, US. The company has a track record of developing hospital-based treatments for which there is substantial unmet medical need. PAION’s strategy is to participate in the commercialization of Remimazolam and extend its business with a focus on anesthesia/critical care products. Remimazolam is the building block for its future marketing activities.
SOURCE: Paion
Post Views: 162
MAHWAH, NJ, USA I June 8, 2015 I PAION, Inc., a wholly owned subsidiary of PAION AG, today announced the initiation of the second pivotal U.S. Phase 3 clinical trial of Remimazolam, an ultra-short-acting sedative/anesthetic, for procedural sedation in patients undergoing bronchoscopy.
The current trial forms the second pivotal study of the Remimazolam Phase 3 program. PAION and the U.S. Food and Drug Administration (FDA) have agreed on the remaining development program (indications, size of studies and design).
Greg Papaz, president and chief executive officer of PAION, Inc., said: “The Phase 3 bronchoscopy study is intended to confirm the efficacy and safety profile of Remimazolam in additional procedural sedation applications with the intention of broadening the target patient population and to achieve a broad label in procedural sedation. Because most patients undergoing bronchoscopy have a pre-existing pulmonary disease, Remimazolam’s benign safety profile including its effect on the respiration system is critically important to its success as a sedative for these procedures. During Phase 2 clinical trials in colonoscopy and upper endoscopy, Remimazolam had an excellent safety profile including respiratory stability and was highly effective in providing sedation resulting in successfully completed procedures.”
This Phase 3 clinical trial is a prospective, double-blind, randomized, placebo- and midazolam-controlled, U.S. multicenter study in 460 patients undergoing bronchoscopies. Patients will be randomized to receive Remimazolam, midazolam or placebo in addition to fentanyl to achieve moderate sedation. The primary endpoint is the successful completion of the bronchoscopy procedure with no requirement for an alternative sedative. The completion of patient recruitment is expected in 2016.
About Remimazolam
Remimazolam is an innovative ultra-short-acting general sedative/anesthetic. As a result of its short duration of action and good controllability, it has a preferable efficacy and safety profile relative to other currently marketed anesthesia compounds. Remimazolam’s rapid offset is a consequence of its metabolism by tissue esterase enzymes that are widely distributed throughout the body. While the key positioning in conscious sedation will be a low impact on respiratory function it will be cardiovascular stability for general anesthesia. Remimazolam has potential in three indications:
- Procedural sedation (Lead indication U.S.)
- General anesthesia (Lead indication EU, Japan)
- ICU sedation (Phase 2 Japan)
Remimazolam is available for licensing outside China, Russia (CIS) Turkey, MENA Region, South Korea and Canada, where the compound is partnered with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm.
About PAION
PAION AG is a publicly-listed Specialty Pharma Company headquartered in Aachen, Germany with further sites in Cambridge, UK and New Jersey, US. The company has a track record of developing hospital-based treatments for which there is substantial unmet medical need. PAION’s strategy is to participate in the commercialization of Remimazolam and extend its business with a focus on anesthesia/critical care products. Remimazolam is the building block for its future marketing activities.
SOURCE: Paion
Post Views: 162
