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FDA Approves Actiq For Breakthrough Cancer Pain SALT LAKE CITY, UT -- Nov. 5, 1998 -- The United States Food and Drug Administration has approved Anesta Corp.’s Actiq(R) (oral transmucosal fentanyl citrate) for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy. Breakthrough cancer pain is a flare of severe cancer pain, which breaks through the medication that is being administered at regular intervals for persistent cancer pain. Breakthrough cancer pain is a component of chronic cancer pain that is particularly difficult to treat due to its severity, rapid onset and frequent unpredictability. Approximately 50 percent of all cancer pain patients, more than 800,000 patients in the U.S., experience breakthrough cancer pain. Actiq is contraindicated in the management of acute or postoperative pain and must not be used in opioid non-tolerant patients. It is intended to be used only in the care of cancer patients by oncologists and pain specialists who are skilled in the use of Schedule II opioids to treat cancer pain. The most common adverse events observed with product use in breakthrough cancer pain patients are somnolence, nausea, vomiting and dizziness, which are generally associated with opioid therapy. Related Links: Anesta Corp. and Actiq E-mail this page to a friend or colleague! To print, use this version