2022-02-11| Policy

FDA to Support Development of Non-Opioid Painkillers

by Sahana Shankar
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Opioids are synthetic and semisynthetic drugs derived from poppy seed extracts which are used for their sedative and analgesic effects. They have been extensively used for acute and chronic pain management since the 1990s. Numerous studies have reported that prescription opioids are associated with increasing rates of addiction, misuse, abuse and overdose.  

The U.S.FDA announced a draft guidance to help pharmas in the development of non-addictive non-opioid pain-killers. The guidance lists criteria for

  1. Drug development programs and clinical data to be generated for pain management indications
  2. Data to support claims that candidates can reduce or eliminate opioid use with supported data
  3. FDA’s expedited review for suitable candidates

The guidance defines the parameters of clinical trials, dose design, treatment duration and primary endpoints for the next generation of non-opioid painkillers. It  is currently limited for acute pain, defined as pain lasting upto 30 days, resulting from tissue injury or surgery. An updated guidance for chronic pain will be added later. 

Related Article: GeneOnline’s Pick: Notable Novel FDA Approved Drugs in 2021

Next-Generation Analgesics

Several companies such as Pacira, Biogen and Ally Therapeutics have developed a non-opioid pipeline to cater to post-surgery and trauma pain management. However, the regulatory procedure for non-opioids is not well defined since there are many differences in the design of clinical trials, measurement of pain relief and modes of action of candidates. 

The guidance will help companies to design their clinical programs and provide significant data to support their claims, since pain intensity is a very subjective experience and it could be difficult to ascribe endpoints to analgesic effects. With a standardized set of rules, FDA hopes to define terms to predict clinical benefits in reasonable terms and foster the development of non-opioids. The draft guidance is open for public comments till April 11, 2022 and a final guidance document will be prepared after consideration of all comments. 

Related Article: Pacira Acquires Flexion for $425 Million to Expand Non-Opioid Painkiller Portfolio

Federal Commitment to Address the Opioid Crisis


The guidance is a part of the larger overdose prevention strategy, developed by the Department of Health and Human Services (HHS) to address the national crisis of opioid addiction and overdose. It focuses on four aspects of the opioid crisis- primary prevention, harm reduction,  evidence-based treatment and recovery support. The guidance is also designed to adhere to the legal requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (SUPPORT Act). 

“Opioid misuse and abuse remain a serious public health crisis facing the country. Preventing new addiction through fostering the development of novel non-opioid analgesics is an important priority for the FDA,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The guidance reinforces the agency’s commitment to confront opioid misuse, abuse and addiction by taking steps to help those with acute pain get access to improved non-opioid treatment alternatives.”

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