SAINT LAURENT, Quebec, April 02, 2019 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leading oral drug delivery company, today announced it has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted 505(b)(2) New Drug Application (“NDA”) for RIZAPORT® VersaFilm™ for the treatment of acute migraines.
The issues cited in the CRL relate to the Chemistry, Manufacturing and Controls section of the application. The Agency requested additional information, but no new bioequivalence study.
"We believe the recommendations stated in the CRL are manageable and we remain committed to working closely with the FDA to make this innovative new oral film product available to people suffering from migraines,” said Horst G. Zerbe, President and CEO of IntelGenx. “To that end, we expect to move quickly, with the objective of resubmitting the RIZAPORT® NDA before the end of Q3-2019.
IntelGenx continues to look forward to working with its partner, Gensco® Pharma, to commercialize RIZAPORT® in the United States upon FDA approval.
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®. Compared to other triptan-based oral medications, rizatriptan demonstrates the highest efficacy and exhibits the shortest Tmax providing quick onset of action for migraine sufferers.
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.
Reference:
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.
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Source: IntelGenx Technologies Corp.