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FDA Should Not Approve Oxycodegol

Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen's Health Research Group, Testifies on Ineffective and Dangerous New Opioid

The U.S. Food and Drug Administration (FDA) must not approve the new opioid oxycodegol, which is closely related to oxycodone, for treatment of chronic low back pain because the medication is not effective for treating this condition and poses a high risk of being abused, Dr. Sidney Wolfe, health researcher at Public Citizen’s Health Research Group, said in testimony today before the FDA’s Drug Safety and Risk Management & Anesthetic and Analgesic Drug Products Advisory Committees.

The one clinical trial that evaluated the effectiveness of oxycodegol showed that it did not provide clinically meaningful pain relief for patients with chronic low back pain. Moreover, a premarket human abuse potential study found that the medication had an abuse potential, when taken orally, comparable to oxycodone. Oxycodone was misused by about 3.7 million people in 2017 and has caused tens of thousands of deaths and nonfatal damage to a much larger number of other patients.

The FDA also has said that there is a lack of data to establish whether the drug is likely to be abused when taken either intravenously or intranasally.

For these reasons, the risks of the oxycodegol exceed its benefits, and the agency should not approve it.

Read Wolfe’s testimony here.