Mundipharma Applies to Market Remimazolam for General Anesthesia in Japan
TOKYO, Dec. 21, 2018 /PRNewswire/ -- Mundipharma has submitted an application to the Japanese Pharmaceuticals and Medical Devices Agency to market Remimazolam for general anesthesia in Japan.
Mundipharma prepared this submission after acquiring the exclusive rights to develop and market Remimazolam in Japan from speciality German pharmaceuticals company, PAION AG, in December 2017.
The efficacy and safety of Remimazolam has been demonstrated in Phase II/III clinical trials in Japan. It has been administered to more than 1,700 healthy adults and patients in domestic and international clinical trials and has shown rapid onset and offset of anesthesia and sedation, as well as positive results on its maintenance of circulation dynamics and safety profile.
Remimazolam is an ultra-short-acting intravenous benzodiazepine anesthetic for anesthesia and conscious sedation for minor invasive procedures. It is rapidly metabolized to an inactive metabolite by tissue esterases and is not metabolized by cytochrome-dependent hepatic pathways.
"This represents an important milestone as we strive to provide patients and doctors access to Remimazolam in Japan," said Mundipharma CEO, Raman Singh. "We are pleased to be leading these efforts because we believe that this innovative anesthetic solution can provide an significant difference for patients compared to current treatment options in Japan." he added.
Mundipharma's independent associated companies are a network of privately owned entities covering the world's pharmaceutical markets. Mundipharma is a prime example of a company that consistently delivers high quality products while standing by the values that represent the company. Our mission is to alleviate the suffering of patients with cancer and non-cancer pain and to substantially improve their quality of life. Mundipharma is dedicated to bringing to patients with severe and debilitating diseases the benefit of novel treatment options in fields such as pain, oncology, oncology supportive care, ophthalmology, respiratory disease and consumer healthcare. For more information please visit: www.mundipharma.com.sg.
PAION AG is a publicly listed specialty pharmaceutical company developing and aiming to commercialize innovative drugs for out-patient and hospital-based sedation, anesthesia and critical care services. PAION's lead compound is Remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic drug candidate for which PAION has completed the clinical development for use in procedural sedation in the U.S. Outside the U.S., PAION is currently focused on the development of Remimazolam for general anesthesia. A full clinical development program for general anesthesia has been completed in Japan. In the EU, PAION initiated a Phase III trial in July 2018. Development of Remimazolam for intensive care unit (ICU) sedation is also part of the longer-term life-cycle plan for Remimazolam. PAION's vision is to become an acknowledged "PAIONeer" in sedation and anesthesia. PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic that has already shown positive results in clinical Phase III trials. In the human body, Remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and is not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, Remimazolam can be reversed with flumazenil to rapidly terminate sedation and anesthesia if necessary. During clinical studies, Remimazolam demonstrated efficacy and safety with around 2,400 volunteers and patients. Data so far indicates that Remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.
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