FDA approves Abstral drug for treatment of breakthrough pain in cancer patients

Orexo AB announces today that its partner ProStrakan Group plc (LSE:PSK) has received approval from the US Food and Drug Administration (FDA) for Abstral®. Abstral® is licensed for the treatment of breakthrough pain in cancer patients, 18 years of age and older, who are already receiving, and are tolerant to, opioid analgesics for their underlying persistent cancer pain. "This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain," said John Jenkins, M.D., director of FDA's Office of New Drugs in the Center for Drug Evaluation and Research.

ProStrakan expects to launch Abstral® in the US during Q1 2011. Launch preparations are at an advanced stage and sales teams have already completed a significant level of training. Abstral® will be the only fast-acting sublingual tablet for breakthrough cancer pain on the US market, where the overall annual market value for fast-acting fentanyl products is $550m. (Source: Wolter Kluwers, August 2010. MAT).

Abstral® is the first product to be approved in the US with the FDA mandated class Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate release fentanyl products. The Abstral® REMS allows appropriate prescriptions to be filled at retail pharmacies as well as providing access to Abstral® within hospitals. "This approval is also a significant step toward reducing the burden on the health care system of implementing REMS programs," added Dr. Jenkins. "When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS."

Abstral is a fast-acting and rapidly disintegrating sublingual tablet formulation of fentanyl citrate designed for oral transmucosal delivery. The product offers an alternative therapeutic choice to patients and clinicians with a simple, patient friendly and predictable way of delivering fentanyl transmucosally while retaining the individualised dose titration aspects required for optimal treatment of breakthrough pain.

Breakthrough pain is an acute and often severe flare of pain, experienced by patients suffering from cancer, which occurs even though a person may be taking opioid pain relief medicine regularly for their persistent pain. It is known as breakthrough pain because it "breaks through" a regular pain medicine schedule. It may be caused by the cancer itself or it may be related to cancer treatment.

Abstral® has been a significant driver of growth for ProStrakan in Europe. The product is now marketed by ProStrakan across the principal European markets - UK, Germany, France, Spain, Italy and Sweden. By June 2010 the product had gained an average share of 24% of the fast-acting fentanyl market across these countries (Source: IMS, June 2010), and recorded Europe-wide sales of £14.1m in the first 10 months of 2010.

Torbjörn Bjerke, President and CEO of Orexo "This US approval of Abstral® is very good news not just for Orexo, but also for the population of cancer patients experiencing very severe pain. This will enable us, through our partner ProStrakan, to provide these patients with very fast, and effective relief from pain in a responsible and managed way. Abstral® is already making a big difference to patients throughout Europe and will soon be launched in other countries as well. Orexo is receiving between 25-30 percent royalties on net sales of Abstral® in Europe and will receive between 23-28 percent royalties on net sales in the US. This is another important step towards making Orexo a specialty pharmaceutical company."

Peter Allen, Chairman & Acting Chief Executive of ProStrakan, said: "FDA approval of Abstral® is another significant step forward for ProStrakan, enabling us to launch our second major oncology support product in the US, the world's largest pharmaceutical market. Abstral® is already being prescribed for patients across Europe who suffer the debilitating effects of breakthrough cancer pain and we believe that the benefits of Abstral's rapid pain relief will be recognised by both clinicians and patients in the US."