Onyda XR (clonidine hydrochloride), a once-daily, extended-release oral suspension developed by Tris Pharma, is now available in the United States for treating Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients aged 6 years and older. This marks the first liquid, non-stimulant option approved in the country for ADHD.
FDA Approval and Clinical Basis
The U.S. Food and Drug Administration (FDA) approved Onyda XR in May 2024 for use as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications. The approval was based on data from several well-controlled trials of clonidine hydrochloride extended-release tablets. These included two 8-week, placebo-controlled trials involving 256 patients and a 40-week, placebo-controlled, randomized-withdrawal study with 135 pediatric patients aged 6 to 17 years.
Clinical Significance
Rakesh Jain, MD, MPH, clinical professor at Texas Tech University School of Medicine, noted the importance of this new option: "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. 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."
Adverse Reactions and Considerations
When used as a monotherapy, the most common adverse reactions reported in clinical trials included somnolence, fatigue, irritability, nightmare, insomnia, constipation, and dry mouth. When used as an adjunct to a stimulant treatment, common adverse reactions included somnolence, fatigue, decreased appetite, and dizziness.
Addressing Unmet Needs in ADHD Treatment
According to the CDC, approximately 11.4% of children aged 3 to 17 years in the US have been diagnosed with ADHD. A national survey indicated that around 30% of children with ADHD did not receive medication or behavioral treatment in 2022. Furthermore, ongoing shortages of stimulant medications have created additional challenges for patients. Onyda XR provides an alternative for those who do not respond well to stimulants or experience negative side effects.
Tris Pharma's Perspective
Manesh Naidu, chief commercial officer at Tris Pharma, stated, "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. 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."
Combination Therapy
Clinicians may prescribe Onyda XR along with a stimulant to treat ADHD symptoms. Combination therapy is becoming an increasingly popular option for patients who need longer durations of drug coverage than a stimulant dose can provide on its own or who hope to avoid common stimulant side effects.
