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FDA Rejects Oral Film for Acute Migraines
The FDA has issued a complete response letter (CRL) regarding the new drug application (NDA) for RHB-103 (RedHill Biopharma Ltd./IntelGenx Corp.) for the treatment of acute migraines.
CRLs are issued by the FDA’s Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude approval of an NDA in its present form.
The questions raised by the FDA in its CRL regarding the NDA for RHB-103 primarily relate to third-party chemistry, manufacturing, and controls (CMC) and to the packaging and labeling of the product. No questions or deficiencies were raised regarding the product’s safety, and the CRL does not require additional clinical studies.
RHB-103 is an oral thin-film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Maxalt (Merck). Rizatriptan is considered to be one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms.
The film dissolves rapidly in the mouth, leading to absorption of the drug through the gastrointestinal tract and into the bloodstream. The administration method of the RHB-103 oral thin film does not require the patient to swallow a pill or to consume water.
Source: RedHill Biopharma; February 4, 2014.