FDA Takes Steps for the Development of Non-Opioid Pain Medications

The U.S. Food and Drug Administration (FDA) is issuing several documents that should lead to smaller clinical trials, faster approvals and quicker launches of novel nonaddictive therapies that are alternatives to opioid pain medications. One of the documents provides drug companies information on what FDA is looking for in non-opioid medications for chronic pain. Another details how manufacturers can show their product reduces patients’ exposure to opioids for acute pain. And, yet another updates drugmakers on how they should assess the risks of illicit use of their drugs. In addition, FDA is withdrawing its existing 2014 guidance to the drug industry on pain medications, which is overly broad, according to FDA Commissioner Scott Gottlieb, and is sometimes a barrier to new products and innovations. This move is FDA’s latest effort to combat the opioid epidemic, which Gottlieb says is one of the agency’s top priorities.