FDA Policy/General

Lucemyra Web Site Home Page False or Misleading: FDA

The homepage of the consumer Web site for BioCorRx Pharmaceuticals’ Lucemyra (lofexidine) tablets for oral use is false and misleading, according to a 3/27 Untitled Letter issued by the CDER Office of Prescription Drug Promotion (OPDP). The letter says the homepage includes a claim that Lucemyra is the only FDA-approved non-opioid medicine proven to help with symptoms of opioid withdrawal.

OPDP says there are other FDA-approved lofexidine products indicated for the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.

The letter also says the home page fails to present information relating to side effects associated with the drug with a prominence and readability reasonably comparable with the presentation relating to its benefits.

“The overall effect of this presentation undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Lucemyra,” OPDP says. “OPDP notes that the risk information can only be accessed if the viewer manually clicks on the header to expand the section. That does not mitigate the Web page’s overall misleading minimization of the risk.”

Finally, the letter says BioCorRx did not submit the Web page to OPDP before it was launched as required by regulations.

The company was told to respond with a list of all promotional materials for Lucemyra that contain similar presentations and a plan to discontinue such communications or stop distributing the drug.

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