FDA Approves RizaFilm
FDA Approves RizaFilm (rizatriptan) Oral Film for the Treatment of Acute Migraine
SAINT LAURENT, Quebec, April 17, 2023 (GLOBE NEWSWIRE) — IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the “Company” or “IntelGenx”), a leader in pharmaceutical films, today announced that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s RizaFilm® VersaFilm® 505(b)(2) new drug application (NDA) for the treatment of acute migraine.1
RizaFilm® is a proprietary oral thin film formulation of rizatriptan benzoate, the active ingredient in Merck & Co.’s Maxalt®. The global migraine drugs market was valued at nearly $3 billion in 2021 and is expected to reach nearly $11 billion by 2030, representing a compound annual growth rate of 15.6%.2
In December 2018, IntelGenx entered into a definitive licensing, development and supply agreement with Gensco® Pharma (“Gensco”) for the exclusive commercialization of RizaFilm® in the United States. Under the terms of the agreement, IntelGenx is entitled to receive royalty payments based on net profits of RizaFilm®; and is eligible to receive pre-specified payments upon the achievement of certain regulatory and commercial milestones.
“Following a successful pre-approval inspection by the FDA of our Montreal manufacturing facility earlier this month, we are thrilled to reach this milestone and excited to soon introduce what will be the first oral thin film for the treatment of acute migraines available in the U.S.,” said Andre Godin, IntelGenx’s President and CFO. “According to the American Migraine Foundation, 39 million or 12% of Americans suffer from migraine, which is the second leading cause of disability nationwide. We are looking forward to working with our commercialization partner, Gensco, to bring this innovative migraine therapeutic to patients seeking convenient administration and quick relief from their pain. In addition to these benefits, RizaFilm® is well suited to the approximately 80% of patients who have migraine-related nausea3, as well as those who have difficulty swallowing.”
1 RizaFilm® is a Registered Trademark of Gensco® Pharma Corporation
2 Reports and Data, Migraine Drugs Market, https://www.reportsanddata.com/sample-enquiry-form/2515
3 Láinez MJA. (2006) Rizatriptan in the treatment of migraine. Neuropsychiatr Dis Treat. 2006 Sep; 2(3): 247–259
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.
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 offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.
Forward-Looking Information and Statements
This document may contain forward-looking information about IntelGenx’s operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’s plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’s actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
Source: IntelGenx Technologies Corp.
Posted: April 2023
- IntelGenx Announces Resubmission of Rizaport New Drug Application – September 26, 2019
- IntelGenx Announces FDA Acceptance of NDA for Anti-Migraine VersaFilm – June 18, 2013
RizaFilm (rizatriptan) FDA Approval History
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