Abstral is a fast disintegrating tablet for sublingual administration of fentanyl intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics. Abstral is based on Orexo´s unique proprietary technology for sublingual administration.
It is estimated that there are in excess of five million people with cancer in Europe(1), that 30% of these suffer pain as a result(2) and that 65% of these have breakthrough cancer pain(3).
Breakthrough cancer pain is a brief and often severe flare of pain experienced by patients suffering from cancer that occurs even though a person may be taking pain relief medicine regularly for their persistent pain. It is known as breakthrough pain because it is pain that "breaks through" a regular pain medicine schedule. For some people, breakthrough pain occurs during certain everyday activities, such as walking or dressing. For others, it occurs unexpectedly without any apparent cause.
Abstral was referred to the CHMP for review in September 2007 and has now gained a positive opinion recommending approval of the product. This will allow ProStrakan to obtain national licences throughout the EU, with launches following their receipt.
In March 2008, Abstral received a Marketing Authorisation for Sweden, which was the Reference Member State (RMS) for the product during the decentralised procedure.
Commenting on Abstral’s European approval, Dr Torbjörn Bjerke, President and Chief Executive of Orexo, said:
“The approval is a fantastic achievement for Orexo and our ability to become a profitable pharmaceutical company. I believe that Abstral will play a major role in the treatment of cancer patients suffering from breakthrough pain.”
“We are very excited to launch Abstral in Sweden as the first country in our joint venture with ProStrakan, which operates in the Nordic countries. I look forward to continue our excellent partnership with ProStrakan”
Sources:
(1) Cancer Prevalence in European Registry Areas. Micheli et al, Annals of Oncology 13: 840-865, 2002
(2) Management of Cancer Pain. Levy M., & Samuel, T Semin Oncol 32: 179-193, 2005
(3) Breakthrough Cancer Pain Characteristics and Syndromes in Patients with Cancer Pain. An International Survey. Caraceni et al, Palliative Medicine 2004; 18: 177 et seq
Contact:
Orexo AB Torbjörn Bjerke, +46 708-66 19 90 President and CEO E-mail: torbjorn.bjerke@orexo.com or Claes Wenthzel, +46 708 62 01 22 / +46 (0)18-780 88 44 Executive Vice President & CFO E-mail: claes.wenthzel@orexo.com
Source: Orexo
