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Panel Endorses Samska, Infers Clinical Benefit For The Hyponatremia Drug

Executive Summary

An FDA advisory panel endorsed Otsuka Pharmaceuticals' Samska (tolvaptan) for hyponatremia June 25 even though the sponsor's post-hoc analysis of a surrogate endpoint did not clearly prove the drug's clinical benefit

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New Drug Approvals & Regulatory Updates, In Brief

Inhaled insulin could be back: After a last-minute delay in the submission of MannKind's NDA for Afresa, FDA has accepted the March 16 filing and given the product a standard review - which puts the user fee deadline in mid-January. The ultra rapid-acting insulin (MannKind is no longer using the term inhaled insulin) is proposed for treatment of adults with type 1 or type 2 diabetes mellitus. Despite being the last oral inhaler insulin still standing in development, MannKind argues the feature that distinguishes Afresa from other insulin products is not the route of administration, but its pharmacokinetic profile (1"The Pink Sheet" DAILY, March 16, 2009). The lung's large surface area provides access to the circulatory system, where pH-sensitive Afresa particles dissolve upon contact with the lung, releasing insulin monomers that enter the bloodstream. The NDA submitted March 16 is based on a 49-study clinical program that included over 5,300 patients. More than 2,450 subjects with type 1 or type 2 diabetes were randomly assigned to treatment in the pooled controlled Phase II/III clinical studies. The clinical pharmacology program included more than 450 subjects exposed to Afresa in single-dose studies, which meets the current guidance from FDA regarding diabetes therapy development

IFRA Hosts Capitol Hill Scent Experience In Timeout From Policy Concerns

The International Fragrance Association North America took a break from its higher-stakes advocacy work Nov. 1 to give lawmakers and congressional staffers a "scent experience." Perfumers from six of the group's biggest members were on hand with "Scents of Home," joined by Monell Center researchers to educate attendees on the mechanics of scent and the important role it plays in people's lives.

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