FDA Approves Once-Daily Nonstimulant for Treatment of ADHD

The Food and Drug Administration (FDA) hasapproved the selective norepinephrine reuptake inhibitor Qelbree (viloxazine extended-release) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in youth 6 to 17 years of age. The nonstimulant drug, which is to be taken once a day, can be swallowed whole or opened and sprinkled into applesauce.The efficacy of Qelbree was evaluated in three multicenter randomized, controlled trials. In the first trial, researchers randomly assigned 477 patients with ADHD aged 6 to 11 to receive Qelbree 100 mg, Qelbree 200 mg, or placebo once daily for six weeks. The patients were evaluated using the ADHD Rating Scale (ADHD-RS-5) and the Clinical Global Impression Improvement (CGI-I) scale at the start of the study and again at six weeks. Patients who received Qelbree 100 mg or Qelbree 200 mg experienced a greater reduction in ADHD-RS-5 total scores and improvements in CGI-I scores over the course of the trial compared with those who received placebo. The second trial involved 313 patients with ADHD aged 6 to 11 who were assigned to Qelbree 200 mg, Qelbree 400 mg, or placebo once daily for eight weeks. As seen in the first trial, patients who received Qelbree 200 mg or Qelbree 400 mg experienced greater reductions in ADHD-RS-5 total scores and improvements in CGI-I scores from baseline to the end of the study.For the third trial, Qelbree was evaluated in patients aged 12 to 17 years: 310 youth with ADHD were randomly assigned to Qelbr...
Source: Psychiatr News - Category: Psychiatry Tags: ADHD ADHD Rating Scale ADHD-RS-5 attention-deficit/hyperactivity disorder bipolar CGI-I Clinical Global Impression Improvement scale FDA Food and Drug Administration nonstimulant Qelbree suicidality Source Type: research

Related Links:

Source: BMJ Comments - Category: General Medicine Source Type: forums
A judge in California has ruled that state prison guards who work in and around facilities’ health care settings must be vaccinated against the coronavirus
Source: ABC News: Health - Category: Consumer Health News Tags: Health Source Type: news
HIGHLANDS RANCH, Colo., Oct. 19, 2021 /PRNewswire/ -- Vivos Therapeutics, Inc. ( " Vivos " or " the Company " ) (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from mild to moderate obstructive sleep apnea (OSA) and snoring, and Candid Care Co. ( " Candid " ), a digital platform for oral healthcare, today announced a new collaboration that will seek to provide patients with a comprehensive, whole-mouth solution to diagnose and treat OSA in adult patients and provide ...
Source: Dental Technology Blog - Category: Dentistry Source Type: news
As of the first week of October, 16 participants in the placebo group had gotten a symptomatic, lab-confirmed COVID-19 infection compared with just three who caught COVID in the vaccinated group.
Source: WebMD Health - Category: Consumer Health News Source Type: news
White House press secretary Jen Psaki said President Biden's approval ratings are so low because people are "tired of fighting" the...
Source: Reuters: Health - Category: Consumer Health News Source Type: news
Rep. Glenn Thompson has tested positive for Covid-19, according to a statement released on Twitter, and is being treated at Walter Reed...
Source: Reuters: Health - Category: Consumer Health News Source Type: news
Rep. Glenn Thompson, R-Pa., has tested positive for the coronavirus and is currently receiving treatment at a hospital.
Source: Reuters: Health - Category: Consumer Health News Source Type: news
The Pfizer vaccine for kids ages 5-11 is 10 micrograms, roughly one third of the dose given to adolescents and adults.WebMD Health News
Source: Medscape Emergency Medicine Headlines - Category: Emergency Medicine Tags: Infectious Diseases News Source Type: news
Source: Reuters: Health - Category: Consumer Health News Source Type: news
Dr. Laura Esserman answers the door of her bright yellow Victorian home in San Francisco’s Ashbury neighborhood with a phone at her ear. She’s wrapping up one of several meetings that day with her research team at University of California, San Francisco, where she heads the Carol Franc Buck Breast Care Center. She motions me in and reseats herself at a makeshift home office desk in her living room, sandwiched between a grand piano and set of enormous windows overlooking her front yard’s flower garden. It’s her remote base of operations when she’s not seeing patients or operating at the hospita...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Source Type: news
More News: ADHD | African Health | Bipolar | Cardiology | Children | Clinical Trials | COVID-19 | Depression | Food and Drug Administration (FDA) | Heart | Hyperactivity | Learning | Mania | Men | Pandemics | Psychiatry | Study | Suicide | Universities & Medical Training | USA Health | Vaccines | Warnings