IntelGenx Announces FDA’s Acceptance of Resubmission of New Drug Application for RIZAPORT

- November 20th, 2018

IntelGenx (TSXV:IGX) (OTCQX:IGXT) announced that its 505(b)(2) New Drug Application resubmission for RIZAPORT oral soluble film 10 mg for the treatment of acute migraines has been accepted for review by the U.S. Food and Drug Administration (“FDA”). As quoted in the press release: RIZAPORT® is a patent protected proprietary oral thin film formulation of rizatriptan benzoate, a … Continued

IntelGenx (TSXV:IGX) (OTCQX:IGXT) announced that its 505(b)(2) New Drug Application resubmission for RIZAPORT oral soluble film 10 mg for the treatment of acute migraines has been accepted for review by the U.S. Food and Drug Administration (“FDA”).

As quoted in the press release:

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, leading to efficient absorption of the drug through the gastrointestinal tract.  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.

Click here to read the full press release.

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