TRN-257 for narcolepsy
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What is TRN-257 for narcolepsy?
TRN-257 is an oral therapy being developed by Tris Pharma for treating symptoms such as excessive daytime sleepiness (EDS) or cataplexy in people with narcolepsy.
Individuals with narcolepsy experience uncontrollable urges to sleep during the day — when EDS occurs — and sudden episodes of muscle tone loss, known as cataplexy. These symptoms arise because the brain can’t properly regulate sleep-wake cycles, leading to fragmented nighttime sleep and the intrusion of sleep aspects into waking hours.
Oxybates are a class of sedative medications believed to modulate brain signaling in ways that improve the quality of nighttime sleep and stabilize sleep-wake cycles, thus helping prevent sleep-related symptoms during the day.
Some available oxybate medications need to be taken twice-nightly, requiring patients to wake up in the middle of the night for a second dose. Another that allows once-nightly dosing is high in sodium, which can have safety risks for people with cardiovascular or kidney problems.
TRN-257 is a new oxybate product intended to overcome both of these limitations. It is designed with Tris’ proprietary technology to be the only option that is both dosed once-nightly and low-sodium.
The therapy is now under regulatory review in the U.S. for the treatment of cataplexy or EDS in adults with narcolepsy and idiopathic hypersomnia, another sleep disorder. A decision is expected later this year.
Therapy snapshot
| Treatment name | TRN-257 |
| Administration | Oral liquid |
| Clinical testing | Under regulatory review in the U.S. |
How will TRN-257 be administered in narcolepsy?
TRN-257 is an oral liquid designed to be taken once nightly at bedtime. The specific dose to be used for people with narcolepsy has not been announced.
TRN-257 in narcolepsy clinical trials
Tris applied for TRN-257’s approval through the 505 (b)(2) pathway. That allows the company to use data from already approved oxybate products to support the therapy’s safety and effectiveness for people with narcolepsy.
These medications are generally found to boost alertness, ease sleepiness, and reduce the frequency of cataplexy attacks in adults with narcolepsy.
Also included in the application were data from pharmacological and safety studies showing that TRN-257 moves through the body as expected and reaches therapeutic levels in the blood.
Data from a validation study also demonstrated TRN-257’s ease of use. That study showed that representative patients could perform critical tasks and use the medication as intended when following the proposed labeling.
TRN-257 side effects
The specific side effect profile of TRN-257 has not been reported, but it is expected to have a similar safety profile to existing oxybate medications. Common side effects of those medications are nausea, vomiting, headache, and dizziness.
More will be known about TRN-257’s specific safety profile if it receives regulatory approval.
Narcolepsy News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. 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.
