Study Demonstrated Rozerem (ramelteon) Does Not Affect Middle-of-the-Night Balance in Older Adults with Insomnia

MINNEAPOLIS, June 13, 2007 /PRNewswire/ -- Two studies presented today demonstrated that Rozerem did not affect body sway at peak plasma levels, nor did it impair middle-of-the-night balance, mobility or memory performance in patients who suffer from chronic insomnia. The results of the studies were presented at the 21st Annual Meeting of the Associated Professional Sleep Societies (APSS).

"These data are important because they show that ROZEREM may be a safe sleep medication for the many older adults who worry about their balance when they need to get up in the middle of the night. These studies also showed that the patients' memories were not affected by ROZEREM the next morning," said Gary Zammit, PhD, director, Sleep Disorders Institute, New York.

ROZEREM works differently from other prescription sleep medications. It specifically targets an area of the brain believed to be involved in the regulation of the body's normal sleep-wake cycle. It is the first prescription sleep medication that is not a controlled substance, and has shown no evidence of abuse or dependence in clinical studies.

ROZEREM Study Design 1: Effect on Body Sway

A total of 275 adults with chronic insomnia received ROZEREM 8 mg, zopiclone 7.5 mg or placebo in a 28-night double-blind treatment period. The primary endpoint was calculated area of center of pressure (COP), in cm2, recorded on the balance platform with eyes open. Zopiclone (Imovane(R) and Zimovane(R)) was used as a positive control. On night 14, patients were given a balance test one-and-a-half hours before dosing. Patients were then given their randomized medications and went to sleep. Approximately two hours after they had taken their treatments, the patients were awakened to take the balance test once again.

Results showed that at the time of predicted near-peak plasma levels, the effect of ROZEREM on body sway was no different from placebo. However, the positive control, zopiclone, did show a statistically significant difference versus placebo at near-peak plasma levels, indicating impairment in body sway. Specific findings showed that the mean log of COP post-dose for placebo was 1.617 cm2 and for ROZEREM 1.497 cm2, (P=0.532). For zopiclone the mean log of COP after dosage was 3.539 cm2, (P<0.001) compared to placebo.

ROZEREM Study Design 2: Middle-of-the-Night Balance, Mobility or Memory Performance

This study evaluated the effects of ROZEREM versus placebo on middle-of- the-night balance, mobility and memory performance in older adults with chronic insomnia, with zolpidem as a positive control. A total of 33 adults age 65 or older with chronic insomnia received ROZEREM 8 mg, zolpidem 10 mg or placebo 30 minutes before bedtime for one night each in this double-blind, placebo-controlled study. Patients were awakened two hours after they were given medication to evaluate standing balance, turning speed and stability, memory and adverse events. The primary endpoint was balance as assessed by NeuroCom EquiTest Sensory Organization Test (SOT) score two hours after dosage. An SOT objectively identifies abnormalities in patients' use of the three sensory systems that contribute to postural control.

Results found that compared to placebo, ROZEREM did not impair middle-of- the-night balance, mobility or memory performance in older adults with chronic insomnia, relative to the positive control zolpidem. A significant decrease in mean SOT composite score was observed between zolpidem and placebo (P<0.001), but not between ROZEREM and placebo (P=0.837). As compared to placebo, ROZEREM results showed:

    -- No significant increase in turn time and turn sway (P=0.776, P=0.982,

       respectively)

    -- Immediate memory recall did not decline significantly (P=0.683)


    As compared to placebo, zolpidem results showed:


    -- Significant increase in turn time and turn sway (P<0.001, both)

    -- Immediate memory recall declined significantly with zolpidem (P=0.002)

Adverse events were reported in 13 patients with zolpidem and seven patients during placebo and ROZEREM treatment; none were reported as serious.

About ROZEREM

ROZEREM(TM) (ramelteon) is indicated for the treatment of insomnia characterized by difficulty with sleep onset. ROZEREM can be prescribed for long-term use. ROZEREM is the first and only prescription sleep medication that has shown no evidence of abuse or dependence in clinical studies,* and has not been designated as a controlled substance. With the exception of ROZEREM, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the U.S. Drug Enforcement Administration. ROZEREM has a unique therapeutic mechanism of action that selectively targets two receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is known as the body's "master clock" because it regulates the sleep-wake cycle.

*ROZEREM is not a controlled substance. A clinical abuse liability study showed no differences indicative of abuse potential between ROZEREM and placebo at doses up to 20 times the recommended dose (N=14). Three 35-day insomnia studies showed no evidence of rebound insomnia or withdrawal symptoms with ROZEREM compared to placebo (N=2082).

Important Safety Information

ROZEREM should not be used in patients with hypersensitivity to any components of the formulation, severe hepatic impairment, or in combination with fluvoxamine. 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. Hypnotics should be administered with caution to patients exhibiting signs and symptoms of depression.

ROZEREM has not been studied in patients with severe sleep apnea, severe COPD, or in children or adolescents. The effects in these populations are unknown. Avoid taking ROZEREM with alcohol. ROZEREM has been associated with decreased testosterone levels and increased prolactin levels. Health professionals should be mindful of any unexplained symptoms possibly associated with such changes in these hormone levels. ROZEREM should not be taken with or immediately after a high-fat meal. ROZEREM should be taken within 30 minutes before going to bed and activities confined to preparing for bed.

The most common adverse events seen with ROZEREM that had at least a 2% incidence difference from placebo were somnolence, dizziness, and fatigue.

For complete Prescribing Information, visit www.ROZEREM.com.

Takeda Pharmaceuticals North America, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc., is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets products for diabetes, insomnia, wakefulness and gastroenterology. Through the Takeda Global Research & Development Center, Inc. the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com.

North America, Inc.

CONTACT: Dave Buckalew of Takeda Pharmaceuticals North America, Inc.,+1-224-554-5486; or Kate Winer of Ketchum, +1-917-301-8406, for TakedaPharmaceuticals North America, Inc.

Web site: http://www.tpna.com/http://www.ROZEREM.com/

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Posted: June 2007

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