#1 FDA launches medical innovation challenge
On May 30, 2018, the U.S. Food and Drug Administration announced the launch of an innovation challenge to address the current opioid epidemic. The goal of the innovation challenge is to encourage the development of medical devices, including digital health technologies and diagnostic tests that could provide novel solutions for pain management and treatment and the screening, preventing or treating opioid dependence and addiction.
Submissions will be accepted from June 1, 2018, through Sept. 30, 2018, and selected applicants will be announced in November 2018. Submissions will be evaluated by a team from the FDA’s Center for Devices and Radiological Health based on three criteria:
- Product feasibility
- Potential public health impact
- Novelty of the concept
Interested groups and individuals should submit applications electronically to CDRH-Innovation-Opioid@fda.hhs.gov on or before September 30, 2018. The FDA indicated that as many meritorious applications as resources permit will be selected.
More information visit:
Click here to read the full press release which included the following statement from the FDA Commissioner Commissioner Scott Gottlieb, M.D.:
“Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis. We must advance new ways to find tools to help address the human and financial toll of opioid addiction. For example, better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids. This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of addiction. We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis.”
#2 Nektar files NDA for first-in-class opioid analgesic with specific CNS-mediated side effects
Nektar Therapeutics announced on May 31, 2018 that they had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for NKTR-181, a powerful opioid that can address lower back pain without causing euphoria, and thus potentially being less addictive than current drugs.
Click here to read the press release:
#3 AMA report shows national progress toward reversing opioid epidemic
A press release from the American Medical Association on May 31, 2018 highlights that a new report by the organization shows a significant decrease in the number of opioid prescriptions written between 2013 and 2017. At the same time, significant increases in the use of prescription drug monitoring programs (PDMPs), training in pain management and substance uses disorders, and access to naloxone (Narcan, Evzio) occurred.
Click here to access the press release:
Patrice A. Harris, MD, MA, Chair AMA Opioid Task Force commented, “While this progress report shows physician leadership and action to help reverse the epidemic, such progress is tempered by the fact that every day, more than 115 people in the United States die from an opioid-related overdose. What is needed now is a concerted effort to greatly expand access to high quality care for pain and for substance use disorders. Unless and until we do that, this epidemic will not end.”
Summary points from the report:
- Opioid prescribing continues to decrease: Physicians have reduced the number of opioid prescriptions nationwide by more than 55 million between 2013 and 2017, a 22% overall decrease. Every state has observed a decrease in opioid prescriptions written.
- State Prescription Drug Monitoring Program databases increasingly used: Between 2014 and 2017, total physicians registered in PDMPs increased from 472,000 to over 1.5 million. Over 241,000 registered between 2016 to 2017 alone. A 121 percent increase in PDMP access and use was seen between 2016 and 2017.
- More educated health care professionals. In 2016 and 2017, the AMA opioid microsite, end-opioid-epidemic.org, was accessed over 19,000 times for education and training resources related to opioid prescribing, pain management, and screening for substance use disorders.
- Naloxone prescribing increases. Between 2016 and 2017, Naloxone prescriptions more than doubled from approximately 3,500 to 8,000 dispensed weekly. As of April, 2018 that number is now 11,600 naloxone weekly prescriptions.
- MAT prescribers increasing. As of May, 2018, more than 50,000 SAMHSA certified-physicians were available to provide buprenorphine in office for the treatment of opioid use disorders across all 50 states. This is a significant increase of over 42 percent in the past year.
Click here to access the report:
The AMA urges policymakers and insurers to remove key barriers to care for pain and substance use disorders, specifically:
- Remove requirements for prior authorizations and other administrative barriers for obtaining medication assisted treatment (MAT) for opioid use disorders.
- Enforce the parity laws for mental health and substance use disorders per the MHPAEA (Mental Health Parity and Addiction Equity Act) passed in 2008.
- Ensure access to non-opioid pain management alternatives that are affordable and covered.
- End the stigma. Continue to emphasize equivalence between with pain or substance use disorders and any other chronic medical condition.