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1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD TRANSMITTED BY FACSIMILE Kirsten Dale Manager, Regulatory Affairs Promotion/Advertising One Takeda Parkway Deerfield, IL RE: NDA # Rozerem TM (ramelteon) Tablets MACMIS # Dear Ms. Dale: The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed a Substance Abuse Patient Profile Sell Sheet (RAM-01071) (Sell Sheet) for Rozerem TM (ramelteon) Tablets (Rozerem) submitted by (Takeda) under cover of Form FDA The Sell Sheet is false or misleading because it makes unsubstantiated superiority presentations, omits and minimizes the risks associated with the use of Rozerem, omits material facts, and makes a misleading claim about Rozerem. The Sell Sheet thus misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 352(a) and 321(n), and FDA implementing regulations. See 21 CFR 201.6(a); cf. 21 CFR 202.1(e)(3)(i); (e)(5); (e)(6)(ii) & (e)(7)(viii). Background According to its FDA-approved product labeling (PI), 1 ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. Rozerem is also associated with numerous risks. The PI contains contraindications for patients who are hypersensitive to Rozerem or any component of the product. The PI also contains a warning for careful evaluation of patients with sleep disturbances, the need for evaluation of primary psychiatric and/or medical illness if insomnia fails to remit after a reasonable period of treatment, as well as worsening of insomnia, or the emergence of new cognitive or behavioral abnormalities, as such symptoms may be the presenting manifestation of a physical and/or psychiatric disorder. The PI also contains warnings pertaining to use in patients with severe hepatic impairment, use in combination with fluvoxamine, cognitive and behavioral changes (including worsening of depression and suicidal ideation in primarily depressed patients), engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery), and confining 1 The PI disseminated with the Sell Sheet, and referred to in this letter, was dated August 18, Although not relevant to the content of this letter, the most recent version of the PI was revised and approved on October 20, 2008.

2 Kirsten Dale Page 2 activities after taking Rozerem to those necessary to prepare for bed. Furthermore, the PI contains precautions against use in patients with severe sleep apnea or severe chronic obstructive pulmonary disease (COPD), use in combination with alcohol, and effects on reproductive hormones in adults (e.g., decreased testosterone levels and increased prolactin levels). In general, the most common adverse reactions with at least 2% incidence difference relative to placebo include somnolence (5% vs. 3%), fatigue (4% vs. 2%), and dizziness (5% vs. 3%). The DOSAGE AND ADMINISTRATION section of the PI states that Rozerem should be taken within 30 minutes of going to bed and should not be taken with or immediately after a high-fat meal. Similar to the precautions cited in the PI, the DOSAGE AND ADMINISTRATION section reiterates that Rozerem should not be used in subjects with severe hepatic impairment, and Rozerem should be used with caution in patients with moderate hepatic impairment. In addition, the PI states that Rozerem should not be used in combination with fluvoxamine, nor should it be used in patients taking other CYP1A2 inhibiting drugs. Unsubstantiated Superiority Presentation/Minimization of Risk Information Promotional materials are misleading if they contain a drug comparison that represents or suggests that a drug is safer or more effective than another drug, when this has not been demonstrated by substantial evidence or substantial clinical experience. The third page of the Sell Sheet presents the following claims and presentation (bolded emphasis in original; underlined emphasis added; footnotes omitted): Rozerem is the only prescription insomnia medication with no evidence of abuse potential... In a meta-analysis report evaluating abuse liability of 19 hypnotic compounds, only Rozerem demonstrated no likelihood of abuse and no detectable toxicity. The above claims are presented in conjunction with a bar graph titled, RELATIVE ABUSE LIABILITY OF 19 HYPNOTIC DRUGS (footnote omitted), which shows Likelihood of abuse and Toxicity scores for various hypnotic drugs. The bar graph shows varying scores of likelihood of abuse and toxicity for 18 drugs, and Rozerem is shown to have a score of zero for both measurements. The above presentation suggests that Rozerem has no likelihood of abuse and no toxicity, in contrast to the other 18 sedatives/hypnotics presented, and is therefore superior to these other drug products. FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Rozerem has no likelihood of abuse and no detectable toxicity compared to the listed drug products. The reference 2 cited to support this presentation assigned relative abuse liability categorized by likelihood of abuse and toxicity based on an across label comparison of Rozerem to the other 18 drugs listed in the above referenced bar graph. An across label comparison does not constitute substantial evidence or substantial clinical experience to support the above claims and presentation. We 2 Griffiths RR, Johnson MW. Relative abuse liability of hypnotic drugs: a conceptual framework and algorithm for differentiating among compounds. J. Clin. Psychiatry. 2005;66(suppl 9):31-41.

3 Kirsten Dale Page 3 acknowledge the inclusion of the footnote at the bottom of the page, Results of a metaanalysis, not a head-to-head study... ; however, this statement is insufficient to mitigate the misleading implication that Rozerem is superior to other sedative/hypnotic drugs with respect to the likelihood of abuse and toxicity, and that it is safer than has been demonstrated. Furthermore, this presentation minimizes the risks associated with the use of Rozerem by implying that Rozerem has no toxicity associated with its use. This presentation is particularly concerning because Rozerem is associated with numerous risks, including potential endocrine toxicity. This presentation also fails to disclose any information about other attributes of Rozerem therapy, including serious risks that are highly material to any decision about whether to prescribe Rozerem or another sedative hypnotic. This presentation is also misleading because it suggests Rozerem is a superior prescription insomnia medication as compared to all the products listed; however the FDA-approved indications for the products depicted in the bar graph are not the same across all products. In fact, several of the drugs (e.g., trazodone, diazepam, and oxazepam) are not FDA-approved for the treatment of insomnia. Furthermore, two of the products listed, flunitrazepam and methaqualone, are not currently approved for any use in the United States. This presentation misleadingly fails to reveal the differences in indications of the products being compared. In addition, the totality of the claims and presentations on the first page of the Sell Sheet misleadingly imply that Rozerem is a superior insomnia treatment option for substance abuse patients compared to the other sedative/hypnotic drugs based solely on the referenced drugs attributes as benzodiazepine receptor agonists or Schedule IV controlled substances. It is misleading to imply that, based solely on these two attributes, Rozerem is a superior treatment option for these patients. This presentation omits material information about other attributes of Rozerem therapy, including serious risks, which are highly relevant to any decision about whether to prescribe Rozerem or another sedative hypnotic. FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Rozerem is safer, more effective, or otherwise superior to the other sedatives/hypnotics listed on the first page of the Sell Sheet. Generally, adequate and well-controlled head-to-head comparative studies are necessary to support claims of superiority. Omission and Minimization of Risk Information Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. Promotional materials are also misleading if they fail to present information about risks associated with a drug with a prominence and readability reasonably comparable to the presentation of information relating to the effectiveness of the drug. The first three pages of the four-page Sell Sheet contain numerous benefit claims for Rozerem, but fail to convey any risk information on these pages. The only specific risk disclosure is relegated to the back cover of the Sell Sheet. In stark contrast to the efficacy claims in the piece, which are presented with colorful tables and graphs, bolded headers, bullets, and use of a significant amount of white space, the risk presentation on the back cover is presented in small font and in single-spaced, paragraph format. As such, this

4 Kirsten Dale Page 4 presentation fails to present risk information with a prominence and readability reasonably comparable to the presentation of information relating to the effectiveness of the drug. Furthermore, this presentation fails to disclose important risk information associated with Rozerem, including WARNING information from the PI about engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery). This risk presentation also minimizes some of the risks that are disclosed. Specifically, the risk presentation states, Hypnotics should be administered with caution to patients exhibiting signs and symptoms of depression. However, according to the WARNINGS section of the PI, In primarily depressed patients, worsening of depression, including suicidal ideation, has been reported in association with the use of hypnotics (emphasis added). By failing to present this information pertaining to suicidality, the Sell Sheet misleadingly suggests that Rozerem is safer than has been demonstrated. Additionally, the Sell Sheet includes the tagline, Proven for sleep. Nonscheduled for added safety (italicized emphasis in original; bolded emphasis added). This claim minimizes the risks associated with Rozerem by suggesting that Rozerem is safer than other sedatives/hypnotics merely because it is not scheduled by the U.S. Drug Enforcement Administration (DEA). As noted above, Rozerem is associated with numerous risks. Its attribute as a nonscheduled drug does not alone confer added safety. Omission of Material Facts Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The header on the back cover of the Sell Sheet includes the claim, You can prescribe Rozerem for as long as you need to (emphasis in original) with the following footnote, Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. Rozerem can be prescribed for long-term use. This claim misleadingly omits important contextual information regarding the long-term use of Rozerem. As stated in the WARNINGS section of the PI, The failure of insomnia to remit after a reasonable period of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia, or the emergence of new cognitive or behavioral abnormalities, may be the result of an unrecognized underlying psychiatric or physical disorder and requires further evaluation of the patient. We acknowledge that the Important safety information section of the Sell Sheet contains the following information, Failure of insomnia to remit after a reasonable period of time should be medically evaluated, as this may be the result of an unrecognized underlying medical disorder. However, this sentence, which is buried in the risk presentation on the back cover of the piece, is not sufficient to provide context for the prominent long-term use claim. Misleading Claim The Sell Sheet includes the following claim, One simple 8-mg dose (emphasis in original; footnote omitted). This claim misleadingly implies that Rozerem s dosing is simple, when this has not been proven with adequate evidence. As described in the DOSING AND ADMINISTRATION section of the PI, Rozerem dosing is associated with detailed instructions

5 Kirsten Dale Page 5 for use and multiple limitations and considerations (see Background section above). Such limitations and considerations do not support simple dosing of Rozerem. FDA is unaware of any adequate evidence to support a claim that Rozerem dosing is simple. If you have data to support this claim, please submit them to FDA for review. Conclusion and Requested Action For the reasons discussed above, the Sell Sheet misbrands Rozerem under the Act, 21 U.S.C. 352(a) and 321(n), and FDA implementing regulations. See 21 CFR 201.6(a); cf. 21 CFR 202.1(e)(3)(i); (e)(5); (e)(6)(ii) & (e)(7)(viii). DDMAC requests that Takeda immediately cease the dissemination of violative promotional materials for Rozerem such as those described above. Please submit a written response to this letter on or before February 11, 2010, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Rozerem that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials. Please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD, facsimile at (301) In all future correspondence regarding this matter, please refer to MACMIS #17711 in addition to the NDA number. We remind you that only written communications are considered official. The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Rozerem comply with each applicable requirement of the Act and FDA implementing regulations. Sincerely, {See appended electronic signature page} Sheetal Patel, Pharm.D. Regulatory Review Officer Amy Toscano, Pharm.D., CPA Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications

6 Application Type/Number Submission Type/Number Submitter Name Product Name NDA ORIG-1 TAKEDA GLOBAL ROZEREM RESEARCH DEVELOPMENT CENTER INC This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature /s/ SHEETAL PATEL 01/28/2010 AMY TOSCANO 01/28/2010

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