Galena Biopharma, Inc., a biopharmaceutical company developing oncology treatments, has entered into an agreement with Orexo AB, a specialty pharmaceutical company based in Sweden, to acquire Abstral (fentanyl) sublingual tablets for sale and distribution in the United States.
Abstral is approved for inadequately controlled breakthrough cancer pain (BTcP) in patients aged 18 years or older who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. BTcP has been shown to affect as many as 40% to 80% of patients with cancer. These patients reported pain episodes about four times per day with a median duration of 30 minutes.
Galena has identified a launch in the fourth quarter of 2013 for the sublingual fentanyl tablets.
Abstral was evaluated in 311 opioid-tolerant cancer patients with BTcP. Of these patients, 270 were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from one to 405 days, with an average duration of 131 days and with 44 patients treated for at least 12 months. The pharmacokinetics of Abstral proved to be dose proportional over the range of 100 to 800 μg.
Abstral is available only through the transmucosal immediate-release fentanyl Risk Evaluation and Mitigation Strategies (REMS) program, which is intended to minimize the risk for misuse, abuse, addiction and overdose. The FDA has standardized key components of the REMS program to facilitate the adoption of a single shared system. These components include the REMS document, the patient–prescriber agreement and the enrollment form.
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Sentiment: Strong Buy