FDA to Replace Analgesic Drug Development Guidance With New Documents

Regulatory NewsRegulatory News | 30 August 2018 |  By 

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday announced that the agency intends to withdraw its 2014 draft guidance on developing drugs and biologics to treat pain and replace it with at least four new guidance documents over the coming year.

The move is part of the agency's efforts to respond to the ongoing opioid epidemic, which have so far included expanding risk evaluation and mitigation strategy (REMS) requirements for opioid drugs, requesting the withdrawal of Opana ER (oxymorphone hydrochloride) from the market and taking enforcement action against companies selling illicit opioids online.

FDA has also encouraged the development of new addiction treatments, abuse-deterrent opioid formulations, non-opioid analgesics and medical devices to treat opioid use disorder and chronic pain.

According to Gottlieb, the 2014 draft guidance Analgesic Indications: Developing Drugs and Biological Products is overly broad and requires too many studies to obtain a general chronic pain indication.

"The new guidance documents will recommend the study of one or two populations for innovators who wish to pursue a more limited indication for specific kinds of pain. This will broaden the range of drug development opportunities that are available," Gottlieb said.

In turn, Gottlieb said the more tailored development could help bring novel treatments for pain to the market more quickly.

Each of the four guidance documents will be aimed at a different aspect of analgesic drug development.

One guidance will focus on the assessment of drugs that can reduce the need to opioids in the treatment of acute pain by demonstrating a clinically meaningful reduction in the use of opioids.

FDA also plans to issue a guidance on the development of new opioids that will include an "updated framework for evaluating the risks associated with intentional or illicit misuse or abuse of drugs."

Additionally, the agency plans develop a guidance to encourage the development of extended-release local anesthetics which could replace the need for systemic oral opioids in certain situations.

Lastly, FDA will issue a guidance detailing the agency's expectations for the development of new non-opioid drugs to treat chronic pain that could provide safer alternatives for patients who require long-term use of analgesic drugs.



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