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Entereg Gets Cautious Approval Recommendation; More Safety Data Needed

Executive Summary

FDA's Gastrointestinal Drugs Advisory Committee overwhelmingly found that GlaxoSmithKline/ Adolor's Entereg (alvimopan) demonstrates convincing efficacy, leading to a positive recommendation for approval, but the panel also expressed concerns about the limited scope of safety data and an inadequate risk management plan

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Entereg’s REMS To Assess Off-Label Use In Quarterly Reports To FDA

Adolor will monitor off-label use of Entereg (alvimopan) under the Risk Evaluation and Mitigation Strategy for the postoperative constipation therapy, but the firm is silent on how it will handle situations of non-compliance with the drug's required controlled distribution system

Entereg’s REMS To Assess Off-Label Use In Quarterly Reports To FDA

Adolor will monitor off-label use of Entereg (alvimopan) under the Risk Evaluation and Mitigation Strategy for the postoperative constipation therapy, but the firm is silent on how it will handle situations of non-compliance with the drug's required controlled distribution system

FDA’s Strongest REMS To Date: Entereg Approved With Controlled-Distribution

Adolor and marketing partner GlaxoSmithKline's post-operative constipation therapy Entereg is the first drug to clear FDA with its highest level of Risk Evaluation and Mitigation Strategy - a required controlled distribution program. Entereg is at least the fifth new drug, and the second new molecular entity, to be approved with a REMS since the new authority granted by the FDA Amendments Act went into effect March 25

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