FDA panels approve nerve stimulator, two new drugs for opiate addiction

Nov 24 2017

FDA panels approve nerve stimulator, two new drugs for opiate addiction

The U.S. Food and Drug Administration (FDA) has approved the first nerve stimulator to treat symptoms of opiate addiction. Also, FDA advisers have voted to recommend approval of two new injectable drugs to treat opiate addiction, Indivior’s  RBP-6000 and Braeburn Pharmaceuticals’  CAM2038. Both drugs would have to be administered by a health care provider in a clinical setting to prevent patients from intravenously self-administering lethal doses.

The stimulator device, known as NSS-2 Bridge, is designed to treat withdrawal symptoms such as joint pain, anxiety, stomach aches and insomnia. Worn behind the ear, it has a battery-powered chip, with several electrodes stimulate nerves in the brain and spinal cord to relieve symptoms. Patients can use the device for up to five days, during the acute phase of opiate withdrawal.

According to the FDA, a study of 73 patients showed a 30 percent decrease in symptoms within 30 minutes of using the device. The agency has previously approved nerve stimulators to treat epilepsy and depression.

While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA is committed to supporting the development of novel treatments, both drugs and devices, that can be used to address opioid dependence or addiction, as well as new, non-addictive treatments for pain that can serve as alternatives to opioids.”

The Bridge Neurostimulation System is an expansion of the FDA’s 2014 approval of the device – then called the electro auricular device – for use in acupuncture.

The NSS-2 Bridge, which is manufactured and marketed by Versailles, Ind.-based Innovative Health Solutions, Inc., is available only by prescription. It is not recommended for use by patients with hemophilia, patients with cardiac pacemakers or those diagnosed with psoriasis vulgaris.

The two new drugs recommended for approval are expected to receive the final OK by the end of this month.

England-based Invidior’s RBP-6000 is an investigational, once-monthly injectable buprenorphine formulation in the company’s Atrigel delivery system for the treatment of adults with moderate-to-severe opioid use disorder (OUD), as part of a complete treatment plan to include counseling and psychosocial support
Invidior is also the developer of Suboxone, the dissolvable film which is placed under the tongue to treat addiction to opioids.

The other new drug, CAM 2038, is also a buprenorphine delivery vehicle, which can be given once per week or once per month, depending on the dosage. It was developed by Camurus Pharmaceuticals, a Swedish firm that has a patented, nanoscale drug delivery system.

According to Camurus, CAM2038 has been successfully evaluated in seven Phase 1-3 clinical trials, including a pivotal Phase 3 efficacy and a long-term safety study. The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse events, the company says.

If approved, CMA 2038 will be marketed for use in prefilled syringes for administration by a health care professional, in weekly (8 mg to 32 mg) and once monthly (64 to 160 mg) injections.