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FDA pushes for development of non-opioid pain medications

August 29, 2018 | The Washington Post

The Food and Drug Administration is planning new steps to encourage the development of nonaddictive alternatives to opioid pain medications, Commissioner Scott Gottlieb said in an interview. As part of the effort, the agency plans to withdraw its existing 2014 guidance to the drug industry on pain medicines. That document is overly broad, Gottlieb said, and is sometimes a barrier to new products and innovations. The current guidelines call for a large number of studies to get FDA approval for general use for chronic pain, he added. Over the next six to 12 months, the agency plans to issue several documents intended to spur development of medications for specific types of pain. The result should lead to smaller clinical trials, faster approvals and quicker launches of novel therapies, Gottlieb said.

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Abuse-proof opioids floundering despite record overdose rate

August 21, 2018 | Bloomberg

Abuse-proof opioids have an uphill battle ahead before they’re widely used despite potential cost savings and the national push to stem the opioid crisis. To study the long-term effects of ADFs successfully, more patients have to be taking them. But before drug companies can get the medicine to patients, insurers and policymakers say they need data proving ADFs are cost effective to justify prescribing them.

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Doctors raise alarm about shortages of pain medications

July 20, 2018 | NPR News

In hospitals across the country, anesthesiologists and other doctors are facing significant shortages of injectable opioids. Drugs such as morphine, Dilaudid and fentanyl are the mainstays of intravenous pain control and are regularly used in critical care settings like surgery, intensive care units and hospital emergency departments.

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As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion

May 30, 2018 | FDA News Release

As part of the agency’s ongoing commitment to address the epidemic of opioid misuse and abuse, the U.S. Food and Drug Administration today launched an innovation challenge to spur the development of medical devices, including digital health technologies and diagnostic tests that could provide novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.

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NIH launches HEAL Initiative, doubles funding to accelerate scientific solutions to stem national opioid epidemic

April 4, 2018 | NIH

National Institutes of Health Director Francis S. Collins, M.D., Ph.D., announced the launch of the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. Toward this effort, NIH is nearly doubling funding for research on opioid misuse/addiction and pain from approximately $600 million in fiscal year 2016 to $1.1 billion in fiscal year 2018, made possible from a funding boost by Congress. One of the efforts will be to pursue public-private partnerships to develop new non-addictive pain medicines.

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