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Biotech / Medical : CEPH - CEPHALON -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (66)	9/24/2003 11:00:19 AM
From: Icebrg	Read Replies (1) \| Respond to of 109

Summary from FDA's briefing document. 7 BENEFIT/RISK ASSESSMENT Excessive sleepiness associated with disorders of sleep and wakefulness can be disabling. The ES experienced by patients with these disorders affects their quality of life and their ability to participate in desired waking activities (e.g., work or school), and may represent a safety risk, not only for the patient but for society in general. For these patients, improving wakefulness (or decreasing ES) is important to allow adequate functioning at home, in the workplace, and while commuting to and from work. PROVIGIL treatment improves wakefulness equally in patients with ES associated with disorders of sleep and wakefulness, regardless of the underlying disorder. The clinical benefits of PROVIGIL have been established in multiple clinical studies using multiple measures, both objective and subjective in nature. Across all disorders and within a disorder, there were statistically significant improvements with PROVIGIL treatment in mean sleep latency as measured by either MWT or MSLT and these improvements were maintained over the course of treatment. Statistically significant improvements in subjectively reported sleepiness were seen in all studies, and PROVIGIL-treated patients showed significant improvement on the basis of clinical impression (CGI-C). PROVIGIL treatment also improves the behavioral consequences of ES. The results of the PVT and SCPT demonstrate the positive effect of PROVIGIL treatment on sustained alertness and vigilance. The results of the studies also support the conclusion that PROVIGIL can have a clinically meaningful impact on some aspects of quality of life for these patients. Across all disorders of sleep and wakefulness studied, PROVIGIL was generally well tolerated, and the adverse events seen have been generally innocuous. The most common adverse events reported in clinical studies were headache, nervousness, nausea, and insomnia. Most of these adverse events were mild to moderate in severity and occurred within the first month of PROVIGIL treatment. PROVIGIL appears to be well tolerated with long-term use, with no new patterns of adverse events observed. PROVIGIL tablets have been marketed in the US since 1999, with approximately 140,000 patient-treatment years of exposure. The safety profile observed with PROVIGIL in postmarketing surveillance is similar to that seen in clinical studies, and the safety profile as it applies to the broader population under consideration appears to be no different than the safety profile as outlined in the current PROVIGIL labeling. On the basis of extensive clinical research, the benefits of PROVIGIL treatment clearly exceed its risks. Furthermore, PROVIGIL treatment is seen as fulfilling an unmet need for improving wakefulness in patients with ES associated with disorders of sleep and wakefulness.