Date: 2012-05-14
Type of
information: Completion of the trial
phase: 2
Announcement: results
Company: Paion (Germany) Ono Pharmaceutical (Japan)
Product: remimazolam
Action
mechanism:
- benzodiazepine derivative. Remimazolam is a short-acting general anaesthetic/sedative. Sedatives are used, for example, in endoscopic procedures such as colonoscopies. After intravenous administration Remimazolam rapidly induces the desired sedation. Importantly, this sedative effect quickly disappears. This rapid offset of the effect of the substance is due to its metabolism by tissue esterase enzymes that are widely distributed throughout the body. Remimazolam is being developed as a sedative agent for day case procedures (procedural sedation) as well as for the induction and maintenance of anaesthesia. It could also be used as a sedative for patients in the Intensive Care Unit (ICU).
Disease: sedation
general anesthesia
Therapeutic
area: CNS diseases
Country: Japan
Trial
details:
Latest
news:
- Paion has announced that its Japanese development partner, Ono Pharmaceutical Co has completed a phase II clinical study of remimazolam (development codes: ONO-2745/CNS 7056), which has been developed by Paion and now its development in Japan is promoted by ONO for general anesthesia. This study was conducted in Japan as an open-label study in surgery patients undergoing general anesthesia in combination with analgesics. Remimazolam was intravenously administered to 85 surgery patients 20 years or older, with the purpose of induction of general anesthesia for 45 patients, and induction and maintenance of general anesthesia for 40 patients.
All 43 patients analyzed among the patients who received remimazolam for induction of general anesthesia achieved loss of consciousness and underwent successful intubation, while all 32 patients analyzed among the patients who received Remimazolam for induction and maintenance of general anesthesia achieved loss of consciousness and underwent successful intubation with successful completion of a surgery without need of rescue therapy for sedative effects.
No adverse events of concern were observed. As expected in 98.8% of patients adverse events were observed due to the nature of the intervention (surgery), including primarily wound complication, laboratory test abnormal, and blood pressure decreased, which correspond with relatively common events typically observed in perioperative patients. There is no concern on safety.
Ono and Paion have entered into a license agreement in August 2007.
Is
general: Yes
