Tag: FDA

FDA gives green light to first medical device to treat ADHD in children: Monarch external Trigeminal Nerve Stimulation System (eTNS)

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The Food and Drug Administration (FDA) approved Friday the first medical device to treat childhood attention deficit hyperactivity disorder, or ADHD.

The device, approved for children ages 7 to 12 who do not currently take ADHD medicine, delivers a low-level electrical pulse to a patch placed on the forehead that interacts with the parts of the brain responsible for ADHD symptoms.

“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.

“Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”

The device, called the Monarch external Trigeminal Nerve Stimulation System (eTNS), is marketed by NeuroSigma and is only available by prescription and must be monitored by a caregiver.

eTNS, which is designed to fit inside one’s pocket, is connected by wire to a patch that is placed on the forehead while sleeping and delivers a “tingling” electrical impulse to branches of the trigeminal nerve.

“While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior,” the FDA said.

The FDA also conducted a trial with 62 children with ADHD in which a group that used eTNS had “significant improvement” in their symptoms as opposed to another group that used a placebo.

Side effects of the treatment include drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. The device should not be placed near a phone or used by children on an insulin pump, pacemaker or implanted neurostimulator, the FDA said.

The FDA found no serious adverse events associated with eTNS.

The device is not currently covered by insurance and has a price tag of just over $1,000 for a starter kit, according to the NeuroSigma website.

https://thehill.com/policy/healthcare/439836-fda-gives-green-light-to-first-medical-device-to-treat-adhd-in-children

New drug approved by U.S. FDA to dissolve chin fat without surgery

On By A.P.In Medicine1 Comment

The Food and Drug Administration will now let you say bye-bye to nasty neck fat and hello to a jawline that doesn’t jiggle. The agency approved the first drug that can eliminate neck fat in most people without surgery.

The drug, known by its commercial name of Kybella, is a deoxycholic acid made by Californa’s Kythera Biopharmaceuticals. This is the same acid your body produces to help it absorb fat. It takes only a few minutes for a licensed dermatologist to inject it under the jawline right into your fat tissue.

The drug immediately goes to work on your wattle, destroying the cell membrane of what doctors call “submental fat,” causing it to burst and go away permanently. That’s great news for patients seeking improvement in an area many people consider a real problem. About 68% of people surveyed by the American Society for Dermatologic Surgery in 2014 named excess fat under the chin and neck one of their top concerns. Many people say they think a double chin makes them look older than they actually are.

Maybe that will make the pain of getting up to 50 injections in a single treatment go down a little bit easier. The good news is it takes only a few days to heal, and there are no bandages necessary to make you look like a Dickensian Jacob Marley’s ghost. But it may take several sessions to eliminate all your problem areas.

The FDA approved the drug after the manufacturer submitted 19 clinical studies involving nearly 2,600 patients. The tests showed the drug worked to eliminate moderate to severe chin fat. Currently, the only other way to delete your double chin is to have surgery, having the fat removed with traditional liposuction. In the past, a drug called Lipodissolve, also known on the streets of Beverly Hills as “lunchtime lipo,” prompted an FDA warning letter in 2010 that suggested that treatment could cause permanent scarring and skin deformities.

Side effects for a small number of patients in the Kybella drug trials included nerve injury in the jaw that lead to a lopsided smile or facial weakness. It also may cause bruising, swelling, redness and some pain in some patients. Insurance does not cover this treatment.

While this drug may be a success for your neck, don’t expect to see it dissolving fat in other problem places, the FDA warns.

“It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area,” Dr. Amy G. Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a news release.

The drug should be commercially available in June, the company said.

http://edition.cnn.com/2015/04/30/health/chin-fat-drug-fda-approval/index.html

Blueberries may be effective in the treatment for post-traumatic stress disorder (PTSD)

On By A.P.In Neuropsychiatric Disease, PTSD, ScienceLeave a comment

Researchers from Louisiana State University have found that blueberries may be effective in the treatment for post-traumatic stress disorder (PTSD). Findings from the study have been presented at the Experimental Biology Meeting in Boston, MA.

Presently, the only therapy approved by the Food and Drug Administration (FDA) for PTSD is selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. Study authors have previously shown that SSRIs increase the level of serotonin (5-HT) and norepinephrine, and that the increased norepinephrine be a possible reason for the reduced efficacy of SSRI therapy.

For this study, the team studied the ability of blueberries to modulate neurotransmitter levels in a rat model of PTSD. Some of the rats received a 2% blueberry-enriched supplement diet and others received a control diet. A third control group consisted of rats without PTSD and received a standard diet without blueberries. Scientists used high-performance liquid chromatography to to measure monoamines and related metabolite levels.

Rats with PTSD who did not receive blueberries showed a predictable increase in 5-HT and norepinephrine level compared with the control group. But rats with PTSD that received blueberries showed a beneficial increase in 5-HT levels with no impact on norepinephrine levels, which suggest that blueberries can alter neurotransmitter levels in PTSD. More studies are needed to understand the protective effects of blueberries and its potential target as a treatment for PTSD.

http://www.empr.com/benefits-of-blueberries-for-post-traumatic-stress-disorder-explored-in-study/article/405810/