Under-the-radar firm IntelGenx has just received FDA approval.

The drug delivery company is focused on the development and manufacturing of pharmaceutical films (oral, fast-dissolving) films, with several products in development, some delivering psychedelic medicines.

While this approval is not for a psychedelic product (RIZAFILM is a film delivery migraine medication), this FDA green light is big news for a company that’s heavily committed to psychedelic development and partnerships.

atai Life Sciences has a substantial ownership stake in IntelGenx of approx 25%, and is using IntelGenx’s film technology for its VLS-01 DMT program.

FDA approval of this delivery technology could help strengthen its case with the FDA for atai’s DMT approval.

See below for some more info and stay tuned to Microdose for more on this.

Congratulations to @IntelGenx on this massive milestone! The FDA has approved the company’s RIZAFILM for treatment of acute migraine, proving the strength of IntelGenx’s technology platform.

IntelGenx is a long-term, important partner for @atai_life, which holds an equity stake…

— Christian Angermayer (@C_Angermayer) April 17, 2023

And see below for information on how atai is using IntelGenx’s film for its DMT program.

If you are interested in finding out more about our program VLS-01 that leverages @IntelGenx oral thin film formulation for TRD, learn more from @SriniGRao below and check out his blog post on VLS-01 that he published last week as part of his weekly series highlighting our… pic.twitter.com/36vtMC9ICH

— atai Life Sciences (@atai_life) April 17, 2023

IntelGenx Announces FDA Approval of RIZAFILM® for the Treatment of Acute Migraine

Partner Gensco® Pharma preparing to commercially launch RIZAFILM® across the United States as soon as is practicable

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® (U.S. market name for RIZAPORT®) 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

About IntelGenx

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.