RedHill Biopharma And IntelGenx Submit Response To FDA CRL For RHB-103

(RTTNews) - RedHill Biopharma Ltd. (RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage drugs, announced, together with IntelGenx Corp. (IGXT.PK, IGX.V) that they submitted a response to the Complete Response Letter or "CRL" of the U.S. Food and Drug Administration or "FDA" for the New Drug Application or "NDA" for RHB-103, an oral thin-film rizatriptan for the treatment of acute migraines.

The companies previously reported on February 4, 2014 that they received the FDA's CRL which raised questions primarily related to third party Chemistry, Manufacturing and Controls (CMC) and to the packaging and labeling of the product. The FDA's CRL did not raise any questions or deficiencies relating to RHB-103's safety and did not require additional clinical studies. RedHill and IntelGenx believe that their response to the FDA addresses all the issues raised in the CRL.

RedHill noted that the company and IntelGenx, a Canadian drug delivery company focusing on oral drug delivery, will continue working with the FDA on the continuing review of the RHB-103 NDA, and will provide additional updates as and when applicable.

RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt. Rizatriptan is considered 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 worldwide annual sales of triptans were estimated to have exceeded $1 billion in 2013.