Regulatory Focus™ > News Articles > Untitled Letter Cites Company for Risk Omissions, Insufficient Trial Strength

Untitled Letter Cites Company for Risk Omissions, Insufficient Trial Strength

Posted 24 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion(OPDP) has sent an untitled letter to New Jersey-based Validus Pharmaceuticals for alleged deficiencies related to a webpage for its drug Bipolar disorder management drug Equetro.

In the 25 June letter to Validus President James Hunter, OPDP noted the drug's "serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis and Steens-Johnson syndrome." The drug's safety profile includes a Boxed Warning as a result of its risks.

OPDP alleges Validus' website omits an entire section on the drug's contraindications and prevautions, as well as a series of other serious warnings to at-risk consumer groups, including pregnant women.

While OPDP said Validus' webpage included a statement imploring consumers to "please see full prescribing information" at a webpage linked in the statement, FDA said the disconnected warning information "does not mitigate the omission of this important risk information."

OPDP also said Validus failed to establish the seriousness of certain risks associated with the drug, including a "direct relationship between [the drug] and suicidal behavior and ideation."

Trials Form Basis of Addition Complaints

Two clinical trials also formed the basis of "unsubstantiated claims" complaints from FDA. The agency claims a company statement that Equetro allowed for the treatment of bipolar disorder without associated weight gain was based on incomplete evidence. "These claims and presentations are misleading because they suggest that patients treated with Equetro will experience no weight gain, when this has not been demonstrated by substantial evidence or substantial clinical experience," wrote OPDP.

An addition trial conducted by Validus and mentioned on its website was cited by FDA, which noted its "significant drop-out rate of approximately 70%" leaving just 24 study participants and the trials' end. The open-label trial was used to substantiate a claim that "Bipolar I Patient treated with Equatro… showed no worsening of depression." Both the size of the trial and its failure to use substantiated methods for evaluating depression raised flags with FDA, which declared that the trial did not constitute "substantial evidence to support claims regarding improvements in depression."

FDA requested the company remove references to the trials in its promotional materials and provide the full prescribing information on its website. An examination of the website on 24 July 2012 found FDA's requested recommendations already made.

Read more:

Untitled Letter to Validus

FDA Screen Capture of Violative Materials

Validus Website for Equetro

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