Hospira Japan receives approval for long term use of Precedex IV sedative

Hospira Japan Co., Ltd. today announced it has received an approval for the long-term (greater than 24 hour) use of the sedative "Precedex IV™200ug" (generic name: dexmedetomidine hydrochloride). This approval follows Hospira's first launches earlier this year of Precedex in Canada and in South Korea, important milestones for Hospira as the company continues to build the molecule's global presence.

Originally, Precedex was approved in Japan in 2004 for sedation of initially intubated and mechanically ventilated patients in the intensive care setting for use up to 24 hours. However, some clinicians specializing in this area were interested in utilizing the product for patients who require greater-than-24-hour sedation.

In response to the clinician interest, Hospira Japan started a series of consultations with the Pharmaceuticals and Medical Devices Agency Japan (PMDA) for the planning of a long-term administration study. As a result of the positive outcome of the study, Japan, one of the largest pharmaceutical markets in the world, became the first market in the Asia-Pacific region to receive approval of over 24-hour usage of Precedex.

"This approval from the Ministry of Health, Labour and Welfare (MHLW) makes Precedex available to a greater number of patients, providing a new sedative tool for patients who are critically ill and require sedation of greater than 24 hours for safety and comfort," said Sumant Ramachandra, M.D., Ph.D., senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. "Our clinical research and development further demonstrates Hospira's commitment to patient safety and improved clinical outcomes."

The clinical study in Japan evaluated safety and efficacy of Precedex long-term administration on patients in the intensive care setting. The study achieved its primary efficacy endpoint: time the patients spent within the targeted sedation range. The results also demonstrated safety of Precedex when used long-term in terms of frequency of side effects and combined administration with other sedatives/ analgesics.

Precedex is a central alpha-2 receptor agonist and it is the first drug in its class approved as a sedative in the intensive care setting. It has been shown to be an effective agent for mild to moderate sedation in the intensive care setting and it reduces the need for opioids without compromising patient comfort. The product is sold in more than 30 markets around the world.

The expanded indication offers an additional option for sedation management in the intensive care setting and more possibilities for sedation/pain management.

"I think it is extremely significant that greater-than-24-hour administration of Precedex in an intensive care unit has become possible, which is a new indication much awaited by healthcare providers," said Makoto Ozaki, M.D., Ph.D., Professor and Chairman of Department of Anesthesiology at Tokyo Women's Medical University, who led the long-term administration study as the principal investigator. "We were often forced to use other sedatives because of the restraint that did not allow us to administer Precedex for more than 24 hours and manage the sedation using the sedative's excellent features, which was really unfortunate. The new indication will allow us to avoid such a situation, and represents significant progress that will be greatly appreciated by patients."

Hospira is continuing its efforts to bring this important medication to new markets. Prior to the approval of long-term use of Precedex in Japan, the product was launched in Canada and South Korea earlier this year.

For Clinicians

Precedex IV ™200ug

Precedex IV™200ug (generic name: dexmedetomidine hydrochloride) is a highly selective central alpha-2 adrenoceptor agonist sedative that provides sedation without causing significant respiratory depression. Precedex was first approved in 1999 in the United States, and is now used in more than 30 nations and regions. In 2004, Precedex was approved and launched in Japan and the sedative is now widely used by the nation's anesthesiologists and intensive care units.

Sedation with Precedex can be continued safely for an extended period, so that sedation can be continued uninterrupted before, during and after mechanical ventilation. Clinically significant episodes of bradycardia, sinus arrest and hypotension have been associated with Precedex infusion and may necessitate medication intervention.