March 27, 2018
NOTE TO REPORTERS
Public Citizen Urges FDA to Reject Approval of Opioid Withdrawal Treatment Medication
Lofexidine Has Not Been Meaningfully Studied
The U.S. Food and Drug Administration (FDA) should not approve lofexidine, a medication that would be used to treat symptoms of opioid withdrawal, because it has not been meaningfully studied and its proposed doses and duration of use in the U.S. are “significantly more dangerous than those for the drug as used in the U.K.,” Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, will say to the FDA today.
The FDA is asking its advisory committee to consider whether treating only withdrawal symptoms in opioid-addicted patients ultimately will help them break their addiction. Wolfe will say that symptom relief is an intermediate outcome that ultimately is meaningless without follow-up addiction treatment.
Lofexidine is approved in the U.K. at a starting dose that is one-fourth of the U.S. proposed starting dose and administered for a much shorter duration. According to Wolfe, the two studies available on lofexidine do not provide enough information about the safety of the proposed longer course of treatment and use subjective symptom scores to claim effectiveness.