In an attempt to tackle the burgeoning opioid epidemic, the U.S. Food and Drug Administration (FDA) has launched a drive to collaborate with public health-minded innovators in developing groundbreaking medical devices to provide new solutions to detect, treat and prevent drug addiction. Through this, the FDA plans to support product developers to design and develop products and technologies that can help address various aspects of the ongoing opioid crisis.
The FDA initiative encourages developers to submit proposals for products that could identify those at risk of addiction, potential drug abuse programs or therapies that eliminate the use of opioid analgesics and devices/technologies that could prevent diversion of prescription opioids. Proposals for the challenge would be accepted from Jun.1 to Sep.30, 2018 and the selected applicants will be announced in November this year. The proposals can be submitted at any stage of development.
The applicants selected by the FDA will work closely with the agency to fast-track development and review of their products. They would have enhanced interactions with the FDA’s review division during the product’s development and evaluation phases. Additionally, products that meet the statutory requirements will be designated as breakthrough devices. The new challenge is also open to those developers who are currently marketing their devices as pain management alternatives to opioids. It will provide additional incentives for product developers to invest in technologies that could address the drug menace.
America’s opioid crisis
Considered to be the worst opioid addiction crisis in the U.S. history, more than 115 Americans become victims of opioid abuse and misuse (prescribed and illicit) every day. Used to treat moderate to severe pain, opioids are safe and effective only when used as prescribed; its misuse can lead to dependence, overdose and addiction.
Among those prescribed opioids for chronic pain, approximately 21 to 29 percent patients end up misusing them. As part of its strategy to tackle the opioid crisis, the FDA has approved more than 200 devices related to treating or managing pain and devices that could be used to treat opioid withdrawal symptoms. From time to time, the agency also evaluates how drugs are being used and takes action accordingly. The latest move will help the agency reduce the scope of the present crisis.
According to FDA Commissioner Dr. Scott Gottlieb, M.D., medical devices can play a key role in addressing the epidemic by reducing the overall opioid use and preventing new cases of addiction. He said that through the initiative, the agency hopes to work with like-minded innovators to identify and accelerate development of new technologies to help reduce the scope of opioid epidemic.
According to FDA’s Center for Devices and Radiological Health Director Dr. Jeff Shuren, M.D., J.D., the latest initiative builds on the agency’s prior work towards a collaborative approach to develop and promote device innovation and safety to help those at risk or suffering from opioid addiction.
Opioid addiction treatment
If you or someone you know is suffering from an addiction to opioids (prescribed or illegal), know that it’s treatable. Sovereign Health of California offers a comprehensive opioid addiction treatment that combines a variety of therapeutic interventions, including behavioral therapies, supervised detox, medication-assisted treatment (MAT) and experiential therapy options to all our patients get their life back on track.
In addition to offering evidence-based care, we also ensure aftercare programs for our patients to help them stay sober even after completion of their treatment and avoid relapse. For more information on various evidence-based treatment programs or to locate our opioid addiction treatment centers, call our live admission specialist at the 24/7 helpline or chat online with a representative.