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BY OUR PHARMA CORRESPONDENT
13 September,2005: The US Food and Drug Administration (FDA) has granted approvable letter to market a new sugar-free pain pill Actiq (fentanyl citrate), Cephalon Inc announced in a press release.
The sugar-free oral formulation, which is bioequivalent to the currently available product Actiq, will be marketed as a treatment option to cancer patients with breakthrough pain.
Actiq is the first medication approved for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
Pain is a primary symptom reported by cancer patients. Of those taking chronic opioid medication for their persistent pain, an estimated 64 to 86 percent experience breakthrough cancer pain. Breakthrough pain is a sudden flare of pain that "breaks through" the relief provided by the pain medication taken around-the-clock to treat underlying persistent pain. The typical episode in cancer patients may peak in as little as three to five minutes, with up to four flares a day. Flares of breakthrough pain are typically severe in intensity and may be excruciating. They often come on suddenly or may be related to a specific activity ("incident pain"). Breakthrough pain can be caused by the cancer itself, treatment, or other cancer-related conditions.
Actiq contains a strong pain-relieving medication (an opioid analgesic) called fentanyl that is used to treat breakthrough cancer pain in patients with malignancies who are taking and who are tolerant to around-the-clock opioid medication for their underlying moderate-to-severe persistent cancer pain.
Actiq is a single-use medicated lozenge, attached to a handle, which delivers fentanyl as the unit is moved along the inside lining of the cheeks. The most serious adverse effects associated with all opioids are respiratory depression (potentially leading to apnea and respiratory arrest), circulatory depression, hypotension, and shock. All patients should be followed for symptoms of respiratory depression. The most common side effects observed in Actiq clinical trials were tiredness, nausea, vomiting, and dizziness. Frequently, however, these adverse events will cease or decrease in intensity with continued use of Actiq, as the patient is titrated to the proper dose.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company into the discovery, development and marketing of products to treat sleep and neurological disorders, cancer and pain. Cephalon currently employs approximately 2,300 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters are located in Maisons-Alfort, France and other European offices are located in Guildford, England, and Martinsried, Germany.
The company currently markets four proprietary products in the United States: Provigil (modafinil), Gabitril (tiagabine hydrochloride), Actiq, and Trisenox (arsenic trioxide) injection, and more than 20 products internationally.
BY OUR PHARMA CORRESPONDENT |
