FDA issues new guidance on opioids

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FDA issues new guidance on opioids

By Sandra Levy - 06/21/2019
The Food and Drug Administration on Thursday issued a new draft guidance, “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework,” which describes the application of the benefit-risk assessment framework that the agency uses in evaluating applications for opioid analgesic drugs. It also summarizes the information that can be supplied by opioid analgesic drug applicants to assist the agency with its benefit-risk assessment, including considerations about the broader public health effects of these products in the context of this crisis.

The agency also is withdrawing the 2014 draft guidance, “Analgesic Indications: Developing Drug and Biological Products.”

The new draft guidance describes what information the FDA recommends companies provide in their opioid analgesic new drug applications in order for the agency to fully assess the benefits and risks and the public health implications of approving their product under the FDA’s current approval authorities. The agency will consider the benefits and risks of proposed new opioid analgesics relative to other already approved opioid and non-opioid analgesics.

In terms of patient safety, the agency recommends that companies consider providing information on whether their drug has any characteristics that would mitigate the risks of overdose, abuse or the development of addiction. Companies also should indicate whether their drugs have novel or greater risks compared to other opioids on the market and also note the public health implications of their products in terms of risks to non-patients, including members of the patient’s household, visiting relatives, friends and others.

Currently, all opioid analgesics intended for outpatient use are subject to one of the FDA-required Risk Evaluation and Mitigation Strategies, or REMS programs. The draft guidance recommends that companies consider whether new products present a different safety profile than those products covered by a currently approved REMS. If so, the company should propose a REMS to ensure that the benefits of the drug outweigh the risks.

The FDA will hold a public meeting on Sept. 17 to further discuss the agency’s benefit-risk assessment of opioid analgesics, including the manner in which risks of misuse and abuse of these products factor into the benefit-risk assessment. This meeting will include a discussion of whether an applicant for a new opioid analgesic should be required to demonstrate that its product has an advantage over existing drugs in order to be approved and, if so, what new authorities the FDA would need to impose such a requirement. In addition, the agency will discuss whether new preapproval incentives (in addition to existing incentives, such as breakthrough designation) are needed to better support and encourage development of all therapeutics – opioid or non-opioid drugs, biological products or devices – intended to treat pain or addiction.

The FDA also plans to issue additional guidance that will outline appropriate clinical endpoints and clinical trial approaches for the development of non-opioid drugs for use in the treatment of acute and chronic pain.