The advantage of Dyanavel XR is in part due to the LiquiXR platform technology developed by Tris Pharma which transforms immediate-release products into one with both immediate- and extended-release properties.
Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders. People are often first diagnosed in childhood, when parents notice they may have trouble paying attention, demonstrate impulsive behaviour, or are overly active.
The exact causes of ADHD are unknown, but genetics may play a key role. Many people are not diagnosed until adulthood and may continue struggling with symptoms that can interfere with daily functioning like focusing or staying organized at work. Treatment is similar in both stages of life and is often a combination of medication and psychotherapy.
Amphetamines are psychostimulants commonly prescribed for ADHD in adults due to specific attributes of the medication — its onset begins early in the day and is maintained into early evening with a single daily dose. On July 22, 2022, Tris Pharma announced in a press release the publication of a study observing the efficacy and safety of the amphetamine tablets Dyanavel XR in adults with ADHD. The Phase III randomized, double-blind, placebo-controlled, fixed-dose study was published in the Journal of Clinical Psychiatry and demonstrated that the tablets are effective and well-tolerated in adults.
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Evaluating Dyanavel XR in Adults
The advantage of Dyanavel XR is in part due to the LiquiXR platform technology developed by Tris Pharma. This technology transforms immediate-release products into one with both immediate- and extended-release properties, which allows patients to take the medication once daily with sustained effects.
During the study, 127 patients between the ages of 18 and 60 were randomized into a 5 mg starting dose group or a placebo group, having the respective treatment administered once daily in the morning. After the third visit, subjects received 20 mg for 14 days before the fifth visit. At their fifth visit, a Permanent Product Measure of Performance (PERMP) test was administered before their morning dose and at 0.5, 1, 2, 4, 8, 10, 12, 13 and 14 hours post-dose. The PERMP total score across all the post-dose timepoints was the primacy efficacy endpoint. Additionally, patient safety was monitored and assessed at each visit.
Overall, the mean PERMP total score was significantly higher in the Dyanavel XR group compared to the placebo group across all post-dose timepoints (302.8 vs 279.6, p=0.0045). Statistically significant improvements were observed at all time points (except 10-, 12- and 14-hours post-dose) in the treatment group as well, compared to the placebo group. Although not statistically significantly greater, the scores at 10, 12 and 14 hours were still improvements compared to placebo group scores. Ultimately, the statistically significant improvements in symptoms and lack of severe adverse events in the treatment group demonstrated that the tablets are an effective and safe treatment option for ADHD symptoms in adults.
RELATED: Qelbree: The First FDA-approved Nonstimulant ADHD Drug for Adults in 20 Years
The Benefits of a Long-Acting Treatment
Andrew J. Cutler, MD, Clinical Associate Professor of Psychiatry at SUNY Upstate Medical University, and principal investigator of the study stated that when looking at the totality of the efficacy results, “coupled with what we know about Dyanavel XR pharmacokinetics and pharmacodynamics, you can see that the drug is working shortly after dosing and is still providing efficacy 13 hours post dose.” The results of this study in adults also build on results from a similar clinical trial in pediatric patients.
Having an option for ADHD symptom relief that extends throughout the entire day can benefit many adults in daily life. As an added benefit, long-acting stimulants result in increased adherence to the treatment as well as a decreased risk of misusing the medication.
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