A “sell sheet” used to promote Rozerem to doctors contained unsubstantiated superiority claims and omitted risks associated with the drug, according to an untitled DDMAC letter posted online.
The sell sheet in question was designed to provide information about prescribing Takeda's Rozerem, a sleep aid, to patients with a history of substance abuse.
The sheet states that “Rozerem demonstrated no likelihood of abuse and no detectable toxicity,” a claim DDMAC disputed.
“FDA is not aware of substantial evidence or substantial clinical experience” demonstrating that claim, the letter said.
Although the Rozerem sheet sourced the claim to an “across label” comparison of 18 other sleep aids, DDMAC said that kind of side-by-side label comparison “does not constitute substantial evidence or substantial clinical experience to support the...claims and presentation.”
In order to support claims of superiority over other products, “adequate and well-controlled head-to-head comparative studies are necessary,” the DDMAC letter said.
Additionally, the sheet's “no toxicity” claim was a “particularly concerning” problem, since Rozerem is associated with potential endocrine toxicity, among other risks, according to the letter.
Takeda was asked to cease using the sell sheet, and to respond in writing with plans for discontinuing the use of such materials.
Rozerem was the sixth best selling sleep aid in 2009, with sales of $81.2 million, according to SDI data. However, that figure represents a 19.5% decline in sales from 2008.
Ambien CR was the best selling drug in the category for 2009, with near-blockbuster sales of $983.3 million, up 13.6% from 2008. Lunesta came in second for 2009, at $813 million, according to SDI.