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Med CheckFull Access

Med Check: Auvelity; Nerivio; eTNS System; and More

Published Online:27 Nov 2022https://doi.org/10.1176/appi.pn.2022.12.12.1

Auvelity Now Available for Treating Major Depressive Disorder

Auvelity (dextromethorphan/bupropion) is now available by prescription for the treatment of major depressive disorder (MDD) in adults, Axsome Therapeutics announced in October. Auvelity targets NMDA and sigma-1 receptors and inhibits aminoketone and CYP450. It is available as dextromethorphan 45 mg/bupropion 105 mg extended-release tablets.

The approval of Auvelity by the Food and Drug Administration (FDA) was based on two large clinical trials. In the GEMINI trial, 327 adults with MDD were randomized to either twice daily Auvelity or placebo tablets. After six weeks, Montgomery-Åsberg Depression Rating Scale (MADRS) scores dropped by an average of 16 points in the patients who took Auvelity compared with 12 points in those who took placebo.

In the ASCEND trial, 97 adults with MDD received either Auvelity or 105 mg bupropion alone twice daily. After six weeks, adults taking Auvelity experienced greater reductions in MADRS scores than those taking bupropion (14 points vs. 9 points, respectively) and greater remission rates (47% vs. 16%, respectively). The changes in MADRS scores were significantly greater in the group receiving Auvelity beginning at week 2.

 

Nerivio Wearable Device May Decrease Patients’ Monthly Migraine Days

In October Theranica Bio-electronics announced that patients with a history of migraine who wore its Nerivio device in a clinical trial experienced a reduction in monthly migraine days compared with patients who wore a sham device. The device, which is worn with an arm band and controlled through an app on the patient’s smartphone, uses remote electrical neuromodulation to activate the body’s natural ability to modulate pain.

In the trial, 248 patients were randomized to use the Nerivio device or a sham device every other day. Those who used the Nerivio device experienced a reduction of four migraine days a month from baseline compared with a reduction of 1.3 days a month among patients who used the sham device.

Nerivio was approved in 2019 for the acute treatment of migraine with or without aura in adults who do not have chronic migraine. It was approved in 2020 for the acute treatment of migraine with or without aura in adults with chronic migraine, and it was approved in 2021 for the acute treatment of episodic or chronic migraine in patients aged 12 years and older.

 

eTNS System to Treat ADHD Now Available

The Monarch eTNS (external Trigeminal Nerve Stimulation) System is now available for use in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 7 to 12 years who are not taking prescription ADHD medications, NeuroSigma Inc. announced at the annual meeting of the American Academy of Child and Adolescent Psychiatry in October. The system was approved by the FDA in 2019. Commercially insured children will be able to obtain the system and the first month’s supply of disposable patches for use with the system for $100, according to a company release. The copay for each additional month of patches will be $40.

While the child sleeps, the device delivers low-level, electrical pulses to the child’s trigeminal nerve via wires and a small patch attached to the child’s forehead. The system’s efficacy was shown in a clinical trial of 62 children with ADHD. The patients randomly received either eTNS or sham nerve stimulation nightly for four weeks. At the study’s completion, the children using the eTNS device had a statistically significant improvement in their ADHD symptoms compared with the sham group, as measured with the clinician-administered ADHD Rating Scale.

 

FDA Announces Shortage of Amphetamine Mixed Salts

In October the FDA announced a shortage of the immediate-release formulation of amphetamine mixed salts such as Adderall, Adderall IR, and similar products that are used to treat ADHD and narcolepsy. Teva, the manufacturer of Adderall, is experiencing intermittent manufacturing delays and has reported to the FDA that it expects problems with supplying the medication through March 2023.

“Until supply is restored, there are alternative therapies including the extended-release version of amphetamine mixed salts available to health care professionals and their patients for amphetamine mixed salts’ approved indications,” the FDA said in a statement. “Patients should work with their health care professionals to determine their best treatment option.■