IntelGenx Facility Undergoes U.S. FDA Pre-Approval Inspection Related to RIZAPORT® NDA
January 30, 2019
SAINT LAURENT, Quebec, Jan. 30, 2019 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) (“IntelGenx”), a leading oral drug delivery company, today announced that the U.S. Food and Drug Administration (“FDA”) has performed a Pre-Approval Inspection (“PAI”) of the company’s Health Canada-certified cGMP manufacturing facility in Montreal. The PAI is related to the IntelGenx New Drug Application (“NDA”) for RIZAPORT®, a VersaFilm™ oral soluble film for the treatment of acute migraines. At the conclusion of the PAI on January 25, the FDA issued a Form 483 with five inspectional observations.
“We appreciate the thoroughness of the FDA’s review of our facility, and we are confident that we will be able to address the FDA’s observations within the 15-day response timeframe,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx. “As we continue to advance through the NDA process, IntelGenx is excited to have completed another important milestone toward U.S. approval.”
The FDA has assigned a Prescription Drug User Fee Act goal date of April 1, 2019, for completion of the review of the resubmitted NDA for RIZAPORT®. IntelGenx does not expect the inspectional observations to impact the timeline for the FDA’s decision on the approval of RIZAPORT®.
In December 2018, IntelGenx entered into a definitive licensing, development and supply agreement granting Gensco® Pharma the exclusive right to commercialize the IntelGenx RIZAPORT® product in the United States.
About RIZAPORT®:
RIZAPORT® is a patent protected 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 to be one of the most effective oral triptans, a class of molecules that constricts blood vessels in the brain to relieve swelling and other migraine symptoms. RIZAPORT® is based on IntelGenx’s proprietary VersaFilm™ technology. It dissolves rapidly and releases its active ingredient in the mouth. The administration method of the RIZAPORT® oral soluble film, which does not require the patient to swallow a pill or consume water, along with its neutral flavor, presents a potentially attractive therapeutic alternative for migraine patients, specifically for patients who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population and patients suffering from dysphagia (difficulty swallowing)1.
References:
1 Lipton RB, Buse DC, Saiers J, Fanning KM, Serrano D, Reed ML. (2013) Frequency and burden of headache-related nausea: results from the American Migraine Prevalence and Prevention (AMPP) study, Headache. 2013 Jan;53(1):93-103.
About IntelGenx
Established in 2003, IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ technology platform.
IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility, which was established for the VersaFilm™ technology platform, offers by supporting lab-scale to pilot- and commercial-scale production. More information about the company can be found at www.intelgenx.com.
AI
