Saturday, June 22, 2024

Attention-deficit/hyperactivity disorder : FDA Approves Nonstimulant Liquid Onyda XR

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Attention-deficit/hyperactivity disorder (ADHD) treatment has taken a significant step forward as the US Food and Drug Administration (FDA) has approved Onyda XR (clonidine hydrochloride), according to an announcement by drug manufacturer Tris Pharma. This marks a significant development in ADHD treatment as Onyda XR is the first approved liquid nonstimulant medication designed for this condition.

Onyda XR is a once-daily extended-release oral suspension that is administered at night. It can be used as a standalone treatment or in conjunction with other FDA-approved stimulant medications for pediatric patients aged six years and older. The nighttime dosing is designed to shift the release profile of the medication, providing a convenient and effective option for patients requiring better ADHD control.

Dr. Ann Childress, a psychiatrist and president of the Las Vegas-based Center for Psychiatry and Behavioral Medicine, emphasized the importance of having diverse therapeutic options for ADHD. “People with ADHD require a range of therapeutic options that are designed for their individual needs, because not every medication or type of therapy works for every patient,” she stated in the release. Dr. Childress highlighted the approval of Onyda XR as a significant addition to the available treatment options, particularly noting its unique formulation as a liquid non-stimulant with nighttime dosing.

The FDA’s approval of Onyda XR was based on “adequate and well-controlled studies” of the extended-release tablets developed by Tris Pharma. These studies provided the necessary evidence of the medication’s efficacy and safety, leading to its approval for use in managing ADHD.

However, it is important to note that Onyda XR is contraindicated for patients with a history of hypersensitivity reactions to clonidine. The medication can cause dose-related decreases in blood pressure and heart rate, making it crucial to monitor vital signs frequently in at-risk patients. During the studies involving extended-release tablets, common adverse reactions included somnolence and sedation. Additionally, the sympatholytic action of clonidine may exacerbate sinus node dysfunction and atrioventricular block, particularly in patients who are taking other sympatholytic drugs.

Attention-Deficit/Hyperactivity Disorder

Attention-Deficit/Hyperactivity Disorder: Onyda XR Expands Treatment Options with Nonstimulant Liquid Formulation for Pediatric Patients

The introduction of Onyda XR adds to the arsenal of ADHD treatments available to healthcare providers, offering a new option for patients who may not respond well to stimulant medications or who require a nonstimulant alternative. The liquid formulation is particularly advantageous for pediatric patients who may have difficulty swallowing pills or tablets.

ADHD is a complex neurodevelopmental disorder characterized by symptoms such as inattention, hyperactivity, and impulsivity. These symptoms can significantly impact daily functioning and quality of life. Effective management of ADHD often requires a combination of medication, behavioral therapy, and educational support. The availability of a nonstimulant liquid medication like Onyda XR provides an additional tool for clinicians to tailor treatment plans to the specific needs of their patients.

Tris Pharma’s development of Onyda XR reflects ongoing efforts to address the diverse needs of individuals with ADHD. By offering a nonstimulant option with a convenient dosing schedule, the company aims to improve treatment adherence and outcomes for patients. The nighttime dosing aspect of Onyda XR may also help manage symptoms more effectively, providing better control throughout the day.

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In conclusion, the FDA’s approval of Onyda XR represents a notable advancement in the field of ADHD treatment. As the first liquid nonstimulant medication approved for this condition, it offers a new therapeutic option for pediatric patients aged six years and older. With its unique formulation and nighttime dosing, Onyda XR has the potential to improve the management of ADHD symptoms, enhancing the quality of life for those affected by this challenging disorder. Healthcare providers now have an additional resource to consider when developing individualized treatment plans for their patients with ADHD.

Resource: Businesswire, May 29, 2024

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