INDICATED FOR MIGRAINE

RIZAPORT® is the first rizatriptan oral disintegrating film for the treatment of migraines to achieve E.U. marketing approval. RIZAPORT® is a new product opportunity formulated using VersaFilm™, IntelGenx’s proprietary oral film technology.

Rizatriptan is a selective 5-HT1B/1D receptor agonist indicated for the treatment of migraines. 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.

The administration method of RIZAPORT® oral soluble film 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. Since the RIZAPORT® film formulation does not require the patient to swallow a pill or consume water, the treatment is especially well-suited for children, elderly patients, and other patients with swallowing difficulties.

RIZAPORT® demonstrated bioequivalence in a successful pivotal clinical trial compared to the reference listed drug Maxalt-MLT® (Merck & Co.). IntelGenx submitted a 505(b)(2) New Drug Application (NDA) for regulatory approval to the U.S. Food and Drug Administration (FDA) in Q1 2013. The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) goal date for completion of the review of the RIZAPORT® NDA of April 1, 2019.  In addition, in October 2018, the Spanish Agency of Medicines and Medical Devices (AEMPS) granted national marketing approval for RIZAPORT® for the treatment of acute migraines.

Global migraine sales are expected to grow to $8.7 billion by 2026, at a Compound Annual Growth Rate (CAGR) of 10.3%2.

Commercialization agreements for RIZAPORT® were signed with Gensco Pharma for the U.S., Grupo JUSTE S.A.Q.F (now Exeltis Healthcare, S.L.) for Spain and Pharmatronic Co. for South Korea.

IntelGenx is currently looking for a partnership or alliance opportunity to commercialize RIZAPORT® in other territories worldwide.

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.
2 GlobalData, Report. 2017 Aug

RIZAPORT® is a registered trademark of IntelGenx Corp.
Maxalt-MLT® is a registered trademark of Merck & Co., Inc.