Applied Clinical Trials
To help combat the nation’s opioid epidemic, FDA is promoting a more tailored approach to developing and testing effective analgesics, with the aim of bringing less addictive pain treatments to market more quickly.
To help combat the nation’s opioid epidemic, FDA is promoting a more tailored approach to developing and testing effective analgesics, with the aim of bringing less addictive pain treatments to market more quickly. This is part of a range of strategies for reducing excessive opioid use and mis-use, while ensuring patient access to effective treatments for pain and addiction.
FDA’s latest step involves issuing a series of guidance documents that map out specific methods for developing more targeted pain and addiction treatments, including abuse-deterrent opioid formulations and analgesics with low- or no-opioid formulations. To set the stage, FDA is withdrawing a 2014 draft guidance on developing drugs and biologics with analgesic indications, explained FDA commissioner Scott Gottlieb in a recent statement [see https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm618831.htm]. The old advisory will be replaced by at least four new guidances in the coming year that aim to shift sponsors away from development programs with multiple large studies designed to support new products with broad indications for treating general chronic pain.
The new advisories will recommend that sponsors study one or two populations with an eye to gaining more expeditious approval of drugs or biologics that treat specific kinds of pain in certain patients. An initial guidance will encourage using this approach in developing low-opioid pain therapies that “demonstrate clinically meaningful reduction” in exposing patients to opioids in treating acute pain. Another document will provide a new framework for evaluating risks associated with the intentional misuse or abuse of new opioid therapies. A third guidance will support the development of extended-release local anesthetics to replace oral systemic opioids in certain situations. And the agency will further advise on developing non-opioid pain therapies to provide safer long-term treatment of chronic pain.
All these strategies for developing and testing innovative pain therapies build on ongoing FDA initiatives to combat opioid abuse and misuse. FDA has strengthened and expanded its REMS (risk evaluation and mitigation strategy) for opioid drugs and has stepped up enforcement actions against online sellers of illicit opioids. Another area of innovation involves developing medical devices and mobile applications to treat pain.
FDA also has engaged the National Academics of Sciences, Engineering and Medicine (NASEM) to help develop new evidence-based guidelines for appropriate prescribing of opioids for acute pain. The aim is to help shape clinical practice and to inform drug labeling for these therapies. Many of these strategies, though, rely on physicians agreeing to prescribe low- and no-opioid medicines, and for health plans to pay for them.
Jill Wechsler is the Washington Correspondent for Applied Clinical Trials.