Industry Briefs

FDA OKs Marketing of Device to Reduce Opioid Withdrawal Symptoms

The Food and Drug Administration (FDA) has approved the use of an electric stimulation device to help to reduce the symptoms of opioid withdrawal, marking the first time a device has been indicated for withdrawal symptoms.

The NSS-2 Bridge is a small device placed behind the patient’s ear that emits electrical pulses to stimulate cranial nerves. These stimulations provide relief from common withdrawal symptoms during the first few days of drug abstinence; these include sweating, tremors, stomach problems, insomnia, and joint pain.

The FDA marketing approval was granted based on an open-label pilot study of the effects of the nerve stimulator on 73 patients undergoing opioid physical withdrawal. The study found that the average clinical opiate withdrawal scale scores of the participants dropped by about 63 percent after 20 minutes of use, and 85 percent after 60 minutes. After five days of use, 64 of the 73 participants (88 percent) successfully transitioned to medication-assisted treatment (MAT). Successful transition to MAT was defined as “those who returned to the clinic and received their first dose of maintenance medication,” the study authors noted in a report published in March in the American Journal of Drug and Alcohol Abuse.

Sunovion Submits New Drug Application for Novel ADHD Medication

Sunovion Pharmaceuticals last month announced that the FDA has accepted for review a New Drug Application (NDA) for dasotraline—a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adults. This drug has an extended half-life (47 to 77 hours) that supports the potential for achieving a continuous therapeutic effect with once-daily dosing.

According to Sunovion, the NDA includes data from multiple placebo-controlled safety and efficacy studies as well as two long-term studies that assessed the safety of dasotraline in people with ADHD for up to one year. These studies, which included about 2,500 people with ADHD, suggest the medication is generally well tolerated, the company said. ■