Abstral is a drug that provides fast and effective treatment of breakthrough pain in cancer patients. It is based on Orexo's sublingual tablet technology and the analgesic fentanyl.
| Name |
Abstral |
| Description |
Sublingual tablet with fast onset of action for the treatment of breakthrough pain in cancer patients |
| Active substance |
Fentanyl |
| Indication |
Breakthrough cancer pain |
| Market size |
Global: USD 1,3bn (Datamonitor 2006) |
| Sales |
Sales across the principal European markets and the US |
| Partners |
ProStrakan, Kyowa Hakko Kirin, Gedeon Richter, NovaMed and Neopharm |
Treatment of breakthrough pain in cancer patients
A large number of patients suffering from cancer pain receive pain-relief treatment with long-acting, strong pain-relief medications such as morphine. Despite this medication, a lot of these patients also experience episodes of transient pain attacks, called breakthrough pain.
Abstral is a drug that provides fast and effective treatment of breakthrough pain in cancer patients who already are receiving opioids for pain treatment. Abstral is based on Orexo's sublingual tablet technology and the analgesic, fentanyl.
Abstral is a fast-dissolving tablet that is placed under the tongue. The benefit is that its active ingredient is absorbed by the body through the mucous membrane. The effect is thereby fast and predictable. The tablet is also easy to use, store and handle.
Regulatory approval and sales
The EMEA recommended approval for the marketing and sale of Abstral in Europe in June 2008 and the product has since been approved for marketing in a number of European countries.
In the US, Abstral was approved by the FDA in January 2011 and Orexo's partner ProStrakan launched the product in the US during Q1 2011.
Abstral was in February 2011 approved by Health Canada, the Canadian Government Department with responsibility for public health. The rights to the Canadian markets were in 2009 sub-licensed by ProStrakan to Paladin.
Marketing and sales
Abstral was launched in Sweden in the third quarter of 2008. Orexo’s and ProStrakan’s joint venture ProStrakan AB has the sales rights for the Nordic countries and is responsible for sales and marketing there.
ProStrakan Group plc has the sales rights for Europe and North America. In early 2009, ProStrakan launched Abstral in the U.K. and Germany. Launches in France, Greece and Spain followed.
Kyowa Hakko Kirin has the sales rights for Japan, where the registration application is being prepared. Distribution agreements for Russia and the CIS (the other countries in the former Soviet Union), Bulgaria and Rumania have been signed with Gedeon Richter. For the Chinese market, Orexo has signed a distribution agreement with NovaMed, and for the Israeli market Orexo has signed a distribution agreement with Neopharm.