Abstral® treats breakthrough cancer pain in patients already being treated with opioids. The product contains the pain-relieving substance fentanyl. Abstral allows doses to be customized according to individual requirements, which is essential for achieving optimal pain relief.
Abstral is a rapidly disintegrating tablet that is placed under the tongue. The advantage is that the active ingredient is absorbed into the body through the mucous membrane. The effect is thereby fast and predictable. The table is easy to dose, store and handle.
The product was approved in 2008 for sales in Europe. Since then it has been launched in most countries in the EU. Abstral is market-leading in Europe among new formulations of fast-acting fentanyl products against breakthrough cancer pain. Abstral is growing very rapidly in Europe and in 2013 is expected to be the market leader among all fast-acting fentanyl-based products.
In January 2011 Abstral was approved by the U.S. Food and Drug Administration, FDA, and was subsequently launched in April by Orexo’s partner ProStrakan. In February 2011 Abstral was also approved in Canada.
In June 2012, ProStrakan acquired the rights in the EU and the rest of the world.
In March 2013, Orexo sold Abstral (fentanyl) Sublingual Tablets in the United States to Galena Biopharma, Inc. For more details - click here.
In September 2013, Abstral was approved in Japan.