FDA approves new ADHD drug for kids
HIV outbreak probe sought
NEW YORK, April 6, (AP): US regulators have approved the first new drug in over a decade for children with ADHD, which causes inattention, hyperactivity and impulsivity.
The Food and Drug Administration late Friday OK’d Qelbree (KELL’-bree) for treating attention deficit hyperactivity disorder in children ages 6 to 17. It comes as a capsule that’s taken daily.
Unlike nearly all other ADHD medicines, Qelbree is not a stimulant or a controlled substance, making it harder to abuse than older drugs. That’s been a problem with earlier ADHD treatments like Ritalin, nearly all of which contain the stimulants amphetamine or methylphenidate.
Qelbree, developed by Supernus Pharmaceuticals of Rockville, Maryland, carries a warning of potential for suicidal thoughts and behavior, which occurred in fewer than 1% of volunteers in studies of the drug.
Supernus wouldn’t disclose the drug’s list price, but it’s sure to be higher than the many cheap generic ADHD pills.
ADHD affects about 6 million American children and adolescents. For many, problems include trouble paying attention and completing tasks, fidgeting and impulsiveness.
Experts say the drug may appeal to parents who don’t want to give their child stimulants.
It also could be an option for kids who have substance abuse problems, dislike the side effects of stimulants or need additional therapy, said Dr. David W. Goodman, director of Suburban Psychiatric Associates near Baltimore and an assistant professor of psychiatry at Johns Hopkins School of Medicine.
Goodman said most ADHD patients taking medication currently are prescribed long-acting stimulants, which are harder to to abuse to get a high than the original, fast-acting versions.
In a key late-stage study funded by Supernus, 477 children ages 6 to 11 took the drug for six weeks. Inattention and hyperactivity symptoms were reduced by about 50% compared to the placebo group. Qelbree, also known as viloxazine, helped reduce symptoms in some study volunteers within a week. Common side effects include sleepiness, lethargy, decreased appetite and headache.
Supernus is in late-stage testing for adults with ADHD. That’s a much smaller group than children, but that market is growing because few adults currently take ADHD medicines.
Antidepressant
Viloxazine was sold as an antidepressant in Europe for several decades, but was never approved by the FDA. The maker ended sales for business reasons nearly two decades ago, as popular pills like Zoloft and Prozac came to dominate the market.
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US Sen Joe Manchin on Monday submitted a congressional inquiry with the Centers for Disease Control and Prevention regarding an HIV outbreak in West Virginia’s largest county.
The West Virginia Democrat asked for the inquiry on behalf of the Kanawha County Commission two months after a CDC official warned that the county’s outbreak was “the most concerning in the United States.”
Commission President Kent Carper said in a statement that the outbreak “is an important public health issue and is deserving of our full understanding.”
In a letter to Dr. Rochelle Walensky, the CDC director, Manchin asked that the CDC review the commission’s concerns and reply by Friday.
Later Monday, Manchin released a letter from the CDC saying it was eager to meet with public health officials. It said Dr. Jonathan Mermin, director of the CDC’s National Center for HIV-AIDS, would be included in the meeting.
In early February, Dr. Demetre Daskalakis, the CDC’s chief of HIV prevention, gave a presentation at a meeting of a Kanawha County HIV task force.
“It is possible the current case count represents the tip of the iceberg,” Daskalakis said. “There are likely many more undiagnosed cases in the community. We are concerned that transmission is ongoing and that the number of people with HIV will continue to increase unless urgent action is taken.”
The commission’s letter to Manchin asked whether the CDC has completed an official investigation into the county’s HIV surge. The letter said the commission is concerned that the statements referring to the outbreak as the most concerning in the nation “are being made without factual and empirical evidence.”
As recently as 2014, only 12.5% of HIV cases in West Virginia were the result of intravenous drug use. By 2019, 64.2% were, according to state health department data. The increase was due primarily to clusters in Kanawha and Cabell counties.
Kanawha County, which includes Charleston and has 178,000 residents, had two intravenous drug-related HIV cases in 2018. The number grew to 15 in 2019 and at least 35 last year, said Shannon McBee, a state epidemiologist.
Diagnosis
By comparison, New York City, with a population of more than 8 million, recorded 36 HIV cases tied to intravenous drug use in 2019, according to the CDC. Counties in other states with populations similar to Kanawha had an average of less than one HIV diagnosis among people who inject drugs, Daskalakis said.
The surge, clustered primarily around the capital of Charleston and the city of Huntington, is being attributed at least in part to the cancellation in 2018 of a needle exchange program that offered clean syringes to injection drug users not able to quit the habit altogether.
Needle exchange programs are included in the CDC’s recommendations for controlling disease outbreaks among intravenous drug users. Such programs exist in dozens of states, but they are not without their critics, including in West Virginia, who say they don’t do enough to prevent or stop drug abuse.
With less than a week left in the regular session, the state Legislature is considering a bill to regulate needle exchange providers.
The nonprofit organization Solutions Oriented Addiction Response provides addicts with clean needles in Charleston and group shares information about HIV testing with residents, including the homeless. SOAR co-founder Sarah Stone has said the legislation could shut down her group’s needle exchange program.
Also: NEUCHATEL, Switzerland:
Masimo announced the results of a prospective, observational study published in Critical Care in which researchers in Genoa, Italy, evaluated the impact of a variety of rescue therapies on the systemic and cerebral oxygenation of mechanically ventilated COVID-19 patients suffering from acute respiratory distress syndrome (ARDS). To gauge the impact, the researchers used the Masimo Root ® Patient Monitoring and Connectivity Platform with O3 ® Regional Oximetry, which uses near-infrared spectroscopy (NIRS) to enable monitoring of tissue oxygen saturation (rSO 2 ) in the region of interest, such as the brain.
Dr. Chiara Robba and colleagues noted that “neurological complications are common in mechanically ventilated critically ill patients with COVID-19 and may lead to impaired cerebral hemodynamics,” and further, that respiratory rescue therapies “may have detrimental effects on brain physiology.” Observing, however, that there is currently little data available regarding the effect of rescue therapies on these patients’ brains, and in particular on cerebral oxygenation, the researchers sought to assess the impact of different ventilatory rescue therapies on the brain to help guide clinicians in choosing the most appropriate therapies for their COVID-19 patients.