P&T COMMUNITY
 
MediMedia Managed Markets
Our
Other
Journal
Managed Care magazine
Login / Register
Join Us  Facebook  Twitter  Linked In

News Categories

 

 

 

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.

More stories