Cephalon, Inc announced that Risk Evaluation and Mitigation Strategies (REMS) for its medications Nuvigil (armodafinil) tablets [C-IV] and Provigil (modafinil) tablets [C-IV] have been approved by the US Food and Drug Administration (FDA). Both the Nuvigil and Provigil REMS consist of a Medication Guide to inform patients about the potential risks associated with the use of these medications, a communication plan and a timetable for submission of assessments of the REMS. The communication plan includes a Dear Healthcare Professional Letter, a Prescriber Brochure, a Pharmacist Action Letter and a dedicated REMS Internet Site. The introduction of the Nuvigil and Provigil REMS programmes is consistent with the company's commitment to safe and appropriate use of its medications.
The goal of each REMS is to inform healthcare providers, patients and caregivers about the risks associated with these medications, including serious skin rash and hypersensitivity reactions. The current product labelling for both medications contains a bolded warning that includes these risks. Neither medication is approved for use in the paediatric population for any indication. In accordance with the approved REMS, the company is currently updating Nuvigil and Provigil labelling to include the Medication Guide.
Nuvigil is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy.
Provigil is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy.
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.