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FDA Agrees to Review Rizatriptan Oral Film Formulation for Acute Migraine

Approval decision expected in February 2014 (June 18)

The FDA has accepted a new drug application (NDA) for RHB-103 (RedHill Biopharma/IntelGenz Corp.), an investigational oral thin-film formulation of the acute migraine drug rizatriptan.

The Prescription Drug User Fee Act (PDUFA) goal date — the targeted date for the FDA to complete its review of the NDA — was set for February 3, 2014.

RHB-103 is a proprietary oral thin-film formulation of rizatriptan benzoate, a 5-HT1 agonist and the active drug in Maxalt (Merck). The triptans are a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms.

According to the product’s developers, the RHB-103 thin film strip dissolves rapidly in the mouth, leading to the absorption of the drug through the gastrointestinal tract and into the bloodstream.

Source: RedHill Biopharma Ltd.; June 18, 2013.

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