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 in Sweden, Germany, UK, Greece, France and Spain |
| 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, Orexo's partner ProStrakan has submitted an NDA to the US Food and Drug Administration (FDA). If an approval is obtained, the product can be launched in the US market int the second half of 2010.
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.