FRAZER, Pa., March 25 /PRNewswire-FirstCall/ -- Cephalon, Inc. announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) to market a new sugar-free formulation of ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II].
ACTIQ is indicated only 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. Once approved, the sugar-free formulation will be marketed for the same indication using the same name. Studies in healthy volunteers demonstrated bioequivalency between the sugar-free and the currently marketed formulation.
"This is the first of five FDA approvals that we will be pursuing over a 15-month time period," said Dr. Paul Blake, Executive Vice President, Worldwide Clinical Research & Regulatory Affairs. "We are pleased that the FDA has met their four-month statutory review target, and we will work with the agency towards final approval of this new formulation. We expect approval in the third quarter of this year."
ACTIQ is the first medication approved for the management of breakthrough cancer pain. 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 medicine 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.
Cephalon currently employs approximately 2,300 people in the United States and Europe. U.S. sites include the company's corporate headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European offices are located in Guildford, England, Martinsried, Germany, and Maisons-Alfort, France.
The company currently markets three proprietary products in the United States: PROVIGIL (modafinil) Tablets [C-IV], GABITRIL(R) (tiagabine hydrochloride) Tablets and ACTIQ(R) and more than 20 products internationally. Further information about Cephalon and full prescribing information on its
U.S. products is available at http://www.cephalon.com/ or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, including the likelihood of FDA approval of the sugar-free formulation of ACTIQ, interpretation of clinical results, including the results of clinical studies of the sugar-free formulation of ACTIQ, manufacturing development and capabilities, market prospects for its product, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.