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Biotech / Medical : Apricus Biosciences -- Ignore unavailable to you. Want to Upgrade?

To: eico20 who wrote (1262)	6/2/2015 5:36:45 PM
From: eico20	Read Replies (1) \| Respond to of 2026

here's an interesting excerpt from Sprout materials, looks like they want to try to manage risks of alcohol and certain type of drug interaction, seems like the biggest issue of this meeting, other safety and efficacy issues seem addressed at this point "While the risk of sedation-related AEs with flibanserin may increase with daytime dosing, in the presence of strong or moderate concomitant CYP3A4 inhibitor use or use with alcohol, the risk is still readily manageable. Sedation-related risks will be minimized in clinical practice through patient and prescriber understanding of the flibanserin safety profile and the importance of bedtime dosing, skipping any missed dose, avoidance of concomitant strong or moderate CYP3A4 inhibitors and a warning that the patient should avoid alcohol consumption until she knows how flibanserin affects her. Hypotension and Syncope AEs No signal for syncope or hypotension-related AEs was noted during conduct of the Phase 3 studies in premenopausal women. Clinically significant AEs of hypotension and syncope were observed in three Phase 1 s tudies of flibanserin that involved daytime dosing and either high exposure due to coadministration of a CYP3A4 inhibitor, direct administration of a supratherapeutic dose of flibanserin, or concomitant and significant alcohol use. No hypotension or syncope AEs were noted in other studies that involved high flibanserin exposure Executive Summary xi Available for Public Disclosure without Redaction Sprout Pharmaceuticals Flibanserin Advisory Committee Briefing Document 4 June 2015 (e.g., supratherapeutic dose study, QT study, driving impairment study, hepatic impairment study). T he proposed flibanserin package insert and Risk Evaluation and Mitigation Strategy (REMS) are designed to mitigate the risk of both CYP3A4 inhibition and excessive alcohol consumption. "