DDMAC letter scolds Rozerem sales aid

Share this article:
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.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete October 2014 Digital Edition

Read the complete October 2014 Digital Edition

Click the above link to access the complete Digital Edition of the October 2014 issue of MM&M, with all text, charts and pictures.

Predicting your pink slip

Predicting your pink slip

Any time a firm needs to save money, high-salaried executives are targets

Private View: New ways to engage with customers

Private View: New ways to engage with customers

These healthcare social media campaigns successfully use emotion, altruism and the human desire to "brand" oneself to get customers engaged.