Onyda XR, First Liquid Nonstimulant for ADHD, Now Available in US
The once-daily, extended release, oral suspension medication was approved by the FDA in May 2024.
Clonidine hydrochloride (Onyda XR) for the treatment of ADHD in pediatric patients 6 years of age and older is now available in the United States, Tris Pharma announced in a release.1 The once-daily, extended release, oral suspension medication is the first liquid, non-stimulant for ADHD approved in the country.
Onyda XR, First Liquid Nonstimulant for ADHD, Now Available in US / Vitalii Vodolazskyi - stock.adobe.com
Clonidine hydrochloride was approved by the FDA in May 2024 and is intended to be used as a monotherapy or as an adjunctive therapy to an approved central nervous system stimulant. In the release, Tris said Onyda XR is available through national pharmaceutical wholesalers and patients can fill prescriptions through their local pharmacy.
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“As the prevalence of ADHD continues to grow, so does the need for the availability of a wider variety of treatment options that meet the unique and individual needs of patients,” Rakesh Jain, MD, MPH, clinical professor at Texas Tech University School of Medicine, said in a release.1 “Until now, there has not been an extended-release oral suspension non-stimulant option available to people with ADHD who may struggle taking pills or require a longer-acting therapy. The availability of Onyda XR represents a meaningful advancement in tailoring treatment to the diverse needs of people with ADHD, and I am excited to now have this important additional medicine available for my patients.”
The approval of clonidine hydrochloride was based on data from several well-controlled trials of clonidine hydrochloride extended-release tablets, including 2, 8-week, placebo-controlled trials evaluating 256 patients, as well as a 40-week, placebo-controlled, randomized-withdrawal study evaluating the drug in 135 pediatric patients aged 6 to 17 years.2
When used as monotherapy for ADHD, the most common adverse reactions included somnolence, fatigue, irritability, nightmare, insomnia, constipation, and dry mouth. When used as an adjunct to a stimulant treatment for ADHD, the most common adverse reactions included somnolence, fatigue, decreased appetite, and dizziness.
According to data from the CDC, an estimated 11.4% of children aged 3 to 17 years in the US have ever been diagnosed with ADHD. Symptoms vary widely in severity, and the presence of comorbid conditions can increase the difficulty of diagnosis and management. Results of a CDC national survey of parents suggests that in 2022, approximately 30% of children with ADHD received neither medication nor behavioral treatment for their condition.3
A shortage of stimulant medications due to growing demand, supply chain issues, telehealth trends, and DEA regulations around the production of controlled stimulant medications has added an additional treatment challenge for patients with ADHD.4
“Non-stimulant ADHD therapies are an increasingly important option for patients who do not respond adequately to stimulant medications or experience negative side effects from them,” Manesh Naidu, chief commercial officer at Tris Pharma, said in a release.1 “As ADHD Awareness Month kicks off, we’re especially pleased that Onyda XR is now available to patients in the United States who might benefit from it as the first-and-only liquid non-stimulant ADHD medication. We look forward to expanding access to this treatment and making a meaningful difference in the lives of those living with ADHD.”
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References
1. Tris Pharma’s Once-Daily ADHD Medication, ONYDA XR (clonidine hydrochloride) Extended-Release Oral Suspension, Now Available in the United States. News Release. Tris Pharma. October 1, 2024. Accessed October 2, 2024. https://www.businesswire.com/news/home/20241001522635/en/Tris-Pharma%E2%80%99s-Once-Daily-ADHD-Medication-ONYDA-XR-clonidine-hydrochloride-Extended-Release-Oral-Suspension-Now-Available-in-the-United-States
2. Tris Pharma Receives U.S. FDA Approval for Once-Daily ONYDA XR (clonidine hydrochloride) Extended-Release Oral Suspension, the First-and-Only Liquid Non-Stimulant ADHD Medication. News Release. Tris Pharma. May 29, 2024. Accessed October 2, 2024. https://www.businesswire.com/news/home/20240529072742/en/Tris-Pharma-Receives-U.S.-FDA-Approval-for-Once-Daily-ONYDA-XR-clonidine-hydrochloride-Extended-Release-Oral-Suspension-the-First-and-Only-Liquid-Non-Stimulant-ADHD-Medication
3. Data and statistics on ADHD. CDC. May 16, 2024. Accessed May 30, 2024. https://www.cdc.gov/adhd/data/index.html
4. Casey C. ADHD medication shortage continues as diagnoses surge. CU Anschutz Medical Campus. March 18, 2024. Accessed May 30, 2024. https://news.cuanschutz.edu/news-stories/adhd-medication-shortage-continues-as-diagnoses-surge
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