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Troriluzole, a new formulation of the approved <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS) treatment riluzole, can be taken with or without food and appears to have better pharmacological properties than approved versions of the medication that allow once daily administration.
That&#8217;s according to data from three studies in healthy volunteers presented by Heather Sevinsky, executive director of clinical pharmacology and pharmacometrics at <a href="https://www.biohaven.com/">Biohaven Pharmaceuticals</a>, which is developing troriluzole.
Sevinsky&#8217;s talk, &#8220;<a href="https://www.aan.com/msa/Public/Events/AbstractDetails/55596">Next Generation Prodrug Troriluzole: Increased Bioavailability of Riluzole with No Food Effect in Healthy Subjects</a>,&#8221; took place at the American Academy of Neurology (AAN) 2024 Annual Meeting held April 13-18 in Denver, Colorado, and online.
Riluzole was approved in the 1990s as the first treatment for ALS. An oral therapy thought to reduce nerve damage by altering neurological signaling, it was originally authorized under the brand name <a href="https://alsnewstoday.com/rilutek-riluzole-for-als/">Rilutek</a>, which is sold as tablets. Other formulations taken as an oral suspension (<a href="https://alsnewstoday.com/tiglutik-for-als/">Tiglutik</a>) or an oral film (<a href="https://alsnewstoday.com/exservan-riluzole-oral-film/">Exservan</a>) have also been approved in more recent years.
Although riluzole has been proven to slow the <a href="https://alsnewstoday.com/stages-of-als/">progression of ALS</a>, the therapy has some notable drawbacks. It can cause liver damage, requires twice daily administration, and has to be taken on an empty stomach because food can prevent the medication from being absorbed properly.
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<h3>Aim is safer, easier formulation</h3>
Troriluzole is a prodrug, an inactive agent that is converted into therapeutic riluzole once inside the body. Biohaven is developing the therapy with the goal of creating a new riluzole formulation that&#8217;s safer and easier to take.
&#8220;Trorilulozole is a novel prodrug that was designed to overcome the shortcomings of oral riluzole,&#8221; Sevinsky said.
Biohaven has conducted three, single-center studies to test the safety and pharmacological effects of a single dose of troriluzole in healthy volunteers.
The first study, which involved 24 participants, compared the bioavailability of troriluzole, at a dose of 100 or 280 mg, against that of oral riluzole at the approved dose of 50 mg. Bioavailability refers to how much of the drug is absorbed into the body.
Results showed that the maximum concentration of active riluzole in the bloodstream was similar for oral riluzole compared with any of the troriluzole doses tested. However, levels stayed higher for longer with troriluzole, such that the total amount of active riluzole in the blood over time was 40% to 50% higher with troriluzole.
Sevinsky noted that troriluzole also led to markedly less variability in levels of riluzole in the bloodstream. Levels varied by about 40% with troriluzole, compared with more than 50% with oral riluzole.
The other two studies, which collectively involved 26 volunteers, tested whether taking troriluzole with food alters how the body absorbs the drug.
Results indicated that, when the 280 mg dose of troriluzole was taken with a fatty meal, the time it took for blood riluzole levels to reach a peak was delayed by about two hours, and the maximum concentration was 20% lower compared with taking the therapy on an empty stomach.
Nonetheless, when considering the total amount of the medication in the bloodstream over time, &#8220;the overall riluzole absorption &#8230; was unaffected by food,&#8221; Sevinsky said.
To put those results in perspective, Sevinsky said that when oral riluzole is taken with a fatty meal, the total amount of drug in the bloodstream over time is reduced by about 20%.
Collectively, these three studies &#8220;confirm higher bioavailability of riluzole when administered as troriluzole and demonstrate troriluzole may be taken without regard to food,&#8221; Sevinsky said.
&#8220;Additionally, results show lower variability of riluzole, representing an optimized profile allowing once daily administration,&#8221; she added, noting that the findings support further development of the new treatment formulation.

AAN 2024: Troriluzole may be taken with food, data suggest

The other evening, our daughter, Sara, read &#8220;<a href="https://youtu.be/oMnjkGv3myg?t=833" rel="nofollow">Bread and Jam for Frances</a>&#8221; aloud while I finished feeding dinner to my husband, Todd. He used to read this children’s book about a young badger with human qualities to Sara when she was little.
In the book, Frances has an aversion to eating anything but bread and jam. She eventually broadens her palette and enjoys a lunch of cream-of-tomato soup and an assortment of other food, “and she made the lobster-salad sandwich, the celery, the carrot sticks, and the olives come out even.”
Todd laughed. He is much the same way, which is something I know all too well because I’ve been feeding him for the last eight years since he became paralyzed due to <a href="https://alsnewstoday.com/what-is-als/">ALS</a>.
When I eat meals, I might mix it up a bit, but I generally work my way around the plate, finishing one item before moving on. I’ll often finish my chicken before I touch my green beans or potato. Without consciously thinking about it, I tend to feed Todd the way I like to eat, where nothing comes out even. And I like to be efficient, so when he finishes a bite of potato, I’ll get his next mouthful ready on the fork.
Todd sighs. “I guess I’ll have another bite of potato.” He prefers to finish a bite of food before deciding what to sample next. But that significantly slows down the process.
I recently found a solution that works for us both: a separate fork for each item.
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<h3>A quality-of-life issue</h3>
Mealtime preferences might seem trivial compared with other aspects of my husband&#8217;s care, such as <a href="https://www.youtube.com/watch?v=Ti23rAGdPR8">toileting</a>, <a href="https://alsnewstoday.com/columns/breathing-easier-support-noninvasive-ventilator/">breathing support</a>, and turning him at night so he can sleep and avoid bedsores. But while he&#8217;s still able to eat, food contributes significantly to his quality of life.
I have a lot on my plate, so it’s easier to cook foods that I like to eat, too. Sometimes Todd will request something new, and it might take me a while to come around to the idea. I agreed to make split pea soup, and I bought the peas, but they sat in the cupboard for a while until I finally made it. It was outside of my normal routine, and I had to plan ahead to soak and boil the peas. But it was easy, and we both liked the soup. I made it again a couple weeks later.
He recently requested chicken wings cooked in our air fryer. I bought a bag of frozen wings, but they’re still in our freezer. I haven’t gotten around to making them yet.
If Todd were healthy, he could cook food for himself. He used to be an excellent cook. But now his desire for variety falls on me.
I don’t always cater to his desires, because I don’t want to cook meals that I don’t like to eat. It’s too much work when I already have to do all the cooking and cleanup. That limits his diet mostly to things that I like, too, or can pick up at the deli or a restaurant.
Sometimes after I cook a meal and I’m about to sit down to eat and feed him, he’ll suggest an add-on.
“Could I get some garlic toast, too?” he’ll ask, even though the spaghetti noodles are an adequate carb.
I don’t say it. It’s a small request, so I pop bread in the toaster and get out the butter and garlic powder.
Navigating the minutiae of daily <a href="https://alsnewstoday.com/living-with-als-2/">life with ALS</a> and paralysis can be challenging. It’s hard for Todd to be so <a href="https://alsnewstoday.com/columns/why-dependency-is-reality-life-with-als/">dependent</a> on me for everything, and it’s hard for me to have him so dependent on me. We both need to practice patience and understanding.
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Note: <a href="https://alsnewstoday.com/">ALS News Today</a> is strictly a news and information website about the disease. It does not provide medical advice, <a href="https://alsnewstoday.com/als-diagnosis/">diagnosis</a>, or <a href="https://alsnewstoday.com/approved-treatments-for-als/">treatment</a>. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of ALS News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to ALS.

Tag: food

AAN 2024: Troriluzole may be taken with food, data suggest

Navigating meal preferences can be tricky with ALS and paralysis