Posts Tagged “FDA”
According to Wikipedia, drug overdoses have become the leading cause of death of Americans under 50, with two-thirds of those deaths from opioids. In 2016, the crisis decreased
The opioid epidemic or opioid crisis is the rapid increase in the use of prescription and non-prescription opioid drugs in the United States and Canada beginning in the late 1990s and continuing throughout the next two decades. The increase in opioid overdose deaths has been dramatic, and opioids are now responsible for 49,000 of the 72,000 drug overdose deaths overall in the US in 2017. The rate of prolonged opioid use is also increasing globally.
The remainder of this text was originally published by NoCamels.com
According to the FDA, Brainsway is set to develop a device for opioid use disorder therapy. The seven other companies, a majority US-based, will develop systems for pain therapy, medication dispensation, overdose detection, drug screening, and virtual reality (VR) treatments for chronic pain.
Medical devices at any stage of development were eligible for the challenge.
The opioid crisis in the US has garnered international attention for its startling statistics. According to the US National Institute on Drug Abuse, 115 Americans die every day from an opioid overdose.
More than 40 percent of all US opioid overdose deaths in 2016 involved a prescription opioid, according to the Centers for Disease Control and Prevention. Overdose rates from prescription opioids were highest among people aged 25 to 54 years, according to the report. And based on data from Substance Abuse and Mental Health Services Administration’s national survey on drug use and health, 11.1 million people aged 12 and older had misused prescription pain relievers in 2017.
The eight companies selected for the FDA innovation challenge will work closely with the agency to “accelerate the development and expedite marketing application review of innovative products, similar to what occurs under the Breakthrough Devices Program“, which helps expedite “certain medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.”
The companies will enter a 90-day collaboration to develop mutual understanding of the product profile including the patient and user needs, and the important risks and benefits, and to discuss the potential regulatory pathways going forward.
“While these products will not automatically receive marketing authorization from the FDA, the device developers will receive increased interaction with CDRH experts, guidance for clinical trial development plans, and expedited review,” wrote Drs. Jeffrey Shuren and Jonathan
“We believe the greatest opportunities for medical devices to help prevent opioid use disorder are devices that could help identify people likely to become addicted, devices that manage pain as an alternative to opioids or reduce the need for opioid medications,” they wrote.
The CDRH has cleared, granted, or approved more than 200 devices related to the treatment or management of pain, including 10 with new or novel technologies…which may reduce the need to administer opioid drugs to patients suffering from either acute or chronic pain, they said.
Brainsway was founded by Abraham Zangen, Yiftach Roth, Avner Hagai