Dexmedetomidine

Dex was developed in the 1990s by Orion and Abbott as a sedative for use in the intensive care unit setting. In 1999, Abbott received FDA approval to market IV Dex, trademarked Precedex® in the United States for ICU sedation. Hospira currently markets Dex in the United States. According to IMS, Precedex® had almost $276 million in sales in 2015. In addition to its initial IV indication as a short term sedative in the ICU and use for procedural sedation, Dex is also marketed as an ICU sedative in the European Union, trademarked as Dexdor®.

Dex is a selective alpha-2 adrenergic agonist that has demonstrated sedative, analgesic and anxiolytic properties. Alpha-2 agonists have been in clinical use since the mid-1960s when clonidine was introduced as an anti-hypertensive drug. While clonidine has demonstrated analgesic effects, it has not been widely used as an analgesic due to its hypotensive side effects. The Dex effect on alpha-2 sub receptors differs from clonodine, resulting in lower reduced propensity to lower blood pressure.

Dex has an extensive history of intravenous use in acute and surgical settings, utilizing its sedative properties. We have formulated Dex at an eighth or a tenth of the dose in the currently recommended IV dosage levels. Based upon our lower dose, we have seen very little sedation, to date, in our clinical trials while still demonstrating an analgesic effect.