FDA Roundup: New Non-Narcotic for Opioid Withdrawal

Hi, I’m Kevin Kunzmann, and welcome to MD Magazine’s weekly FDA Roundup. Here’s your top FDA headlines from this past week.

This week the FDA approved neurostimulation device Drug Relief as a non-narcotic option to aid in alleviating opioid withdrawal symptoms. Drug Relief sends electrical pulses through fine needles inserted in the ear over the course of 120 hours, and reduces symptoms such as anxiety, agitation, depression, nausea, and opiate cravings.

Similarly, MindMotion GO, a portable neurorehabilitation device, was approved for patients with mild to lightly severe neurological impairments, or for those in the recovery phase of rehabilitation. The device is equipped with a variety of gamified engaging activities which cover motor and task functions, and includes a 3D virtual environment.

The FDA also approved rituximab for the treatment of adults with pemphigus vulgaris, a rare, life-threatening autoimmune disease characterized by progressive blistering of the skin and mucous membranes. It became the first biologic therapy approved for the condition, and the first major advancement in its field in 6 decades.

The SOFIA catheter was granted a new indication this week which allows it to help remove blood clots blocking a vessel in the brain during a thrombectomy procedure, and restore the blood flow bringing oxygen and nutrients to that area of the brain. The catheter was originally approved provide contact aspiration technique for revascularization among patients with acute ischemic stroke, secondary to intracranial large vessel occlusive disease.

Lastly, following a productive Breakthrough Designation meeting with the FDA, Sage Therapeutics has announced intentions to expedite its new drug application submission of SAGE-217 for indications in treating patients with major depressive disorder or postpartum depression. The oral receptor inhibitor will complete placebo-controlled phase 3 trials for either indication later this year, and expected to submit their application upon completion of analysis.

For these stories and more, visit us at MDMag.com. This has been Kevin Kunzmann with your FDA Roundup, thank you for watching.