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FDA Says “Everything is on the Table” Regarding the Development of New Pain Drugs

August 29, 2018
Four new guidance documents will both streamline and broaden the range of novel opioid and non-opioid medications.

As the US Congress prepares to return to session after Labor Day, FDA Commissioner Scott Gottlieb, MD, has taken the opportunity to outline his agency’s work on the opioid crisis over the past 8 months. In an August 30 statement reviewing efforts that have included the extension of a risk-evaluation-mitigation strategy for immediate-release opioids and the targeting of illicit opioid-selling websites, to the updating of abuse-deterrent formulation guidance and new goals to create evidence-based opioid prescribing guidelines, Dr. Gottlieb applauded the success achieved thus far.

Perhaps most noteworthy, however, was his announcement of plans to withdraw the FDA’s Guidance for Industry: Analgesic Indications: Developing Drug and Biological Products. Focused on the development of new pain medications, the 2014 guidance “called for a large number of studies to get a general chronic pain indication and may have been difficult to implement because it was so broad,” he said, adding that, “We’ve determined that a more focused approach would streamline drug development in specific areas.”

Going forward, FDA will, therefore, issue four or more new guidance documents within the next year to replace the 2014 document. Specifically, these new guidelines will “recommend the study of one or two populations for innovators who wish to pursue a more limited indication for the treatment of specific kinds of pain” in order to “broaden the range of new drug development opportunities that are available” and to bring products to market “more efficiently.”

The first guidance, already in the works, will address medications that can spare the use of opioids in the treatment of acute pain, including how sponsors can demonstrate a clinically meaningful reduction in the use of opioid pain medications in the acute setting.

A second guidance will focus on assessing the benefits and risks of developing new opioid pain drugs, including the drafting of an updated framework for evaluating the risks associated with intentional or illicit misuse or abuse of these substances.

The third guidance will “outline a path for developing extended-release local anesthetics,” including clinical pharmacology, proper evaluation of safety and efficacy, and the types of studies that may support approval of these products.

Finally, FDA will issue guidance on the development of “new non-opioid pain medications for chronic pain that can provide therapeutic alternatives to the use of opioids.”

Concluded Dr. Gottlieb, “These are just some of the new steps we’re taking to promote innovation for alternatives to opioid drugs for those who need treatment for acute and chronic pain,.... This is an all-of-the-above approach. Everything is on the table.”



Last updated on: August 29, 2018
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FDA Adds Immediate-Release Opioids to REMS Program
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