FRAZER, Pa., Oct. 14 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that a Risk Evaluation and Mitigation Strategy (REMS) for its antiepileptic medication GABITRIL(R) (tiagabine hydrochloride) has been approved by the U.S. Food and Drug Administration (FDA). The GABITRIL REMS consists of a Medication Guide to inform patients about the potential risks associated with the use of GABITRIL. The implementation of the REMS is a result of FDA's identification in 2008 of an increased risk of suicidal thoughts and behavior with the class of antiepileptic drugs (AEDs) which includes GABITRIL. The current product labeling already contains a warning that includes this risk. The addition of a Medication Guide for patients and ongoing assessment of the REMS program is consistent with the company's commitment to safe and appropriate use of its medications.
The GABITRIL Medication Guide will be available on the product website, www.gabitril.com, and will be dispensed with every prescription. The three-pronged REMS assessment plan will be implemented on an ongoing basis to evaluate (1) patients' understanding of the potential serious risks associated with the medication; (2) the distribution and dispensing of the Medication Guide; and (3) adherence to distribution and dispensing requirements as well as corrective actions taken to address noncompliance. In accordance with the approved REMS, the company is currently updating all labeling related to GABITRIL to include the Medication Guide.
GABITRIL is indicated as an adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
Important Safety Information
Postmarketing reports have shown that GABITRIL use has been associated with new onset seizures and status epilepticus in patients without epilepsy. Safety and effectiveness of GABITRIL have not been established for any indication other than as adjunctive therapy for partial seizures. In nonepileptic patients who develop seizures while on GABITRIL treatment, GABITRIL should be discontinued and patients should be evaluated for an underlying seizure disorder.
Antiepileptic drugs (AEDs), including GABITRIL, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
GABITRIL should be withdrawn gradually to minimize the potential of increased seizure frequency, unless safety concerns require a more rapid withdrawal. In clinical trials, the most common adverse events for GABITRIL in combination with other anticonvulsants were dizziness/lightheadedness, asthenia/lack of energy, somnolence, nausea, nervousness/irritability, tremor, abdominal pain, and thinking abnormal/difficulty with concentration or attention.
About Cephalon, Inc.
Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients in several therapeutic areas. Cephalon has the distinction of being one of the world's fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 4,000 people worldwide. The company sells numerous branded and generic products around the world. In total, Cephalon sells more than 150 products in nearly 100 countries. More information on Cephalon and its products is available at www.cephalon.com.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide the Cephalon current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products; 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 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.
SOURCE Cephalon, Inc.