New ramelteon data presented at AARC

December 03, 2007

Orlando, FL December 3, 2007 - A new study presented today showed that ramelteon did not exacerbate respiratory depressant effects in patients (40 years and older) with moderate to severe chronic obstructive pulmonary disease (COPD), as measured by oxygenation or abnormal breathing events relative to placebo. Results of this double-blind, placebo-controlled trial were presented at the 53rd International Respiratory Congress of the American Association for Respiratory Care.

"Getting adequate sleep is essential to maintaining health in people who live with COPD. These results suggest that ramelteon is a sleep medication that can be used safely in adults suffering from moderate to severe COPD who are concerned with breathing impairment during sleep," said Thomas Roth, PhD, director, Henry Ford Sleep Research and Disorders Center. "While traditional sleep aids can negatively affect respiration during sleep in patients with COPD, this study demonstrated that ramelteon does not produce such respiratory depressant effects."

According to the National Institutes of Health, more than 12 million Americans are currently diagnosed with COPD. It is the fourth leading cause of death in the United States and causes serious, long-term disability.

"Patients with COPD - usually characterized by a combination of chronic bronchitis and emphysema - must take extreme care in ensuring they receive enough oxygen at all times, particularly when sleeping. Other medications used for insomnia may reduce upper airway muscle tone, which can lead to increased hypoxemia," said Dr. Roth. "This study shows that there was no difference in blood oxygen saturation all night between placebo and ramelteon."

Study Design

A total of 25 adults age 40 or older with moderate to severe COPD were randomized to receive ramelteon 8 mg or placebo 30 minutes before overnight monitoring of oxygen saturation (SaO2) by pulse oximetry and sleep by polysomnography. After a five- to ten-day washout, patients crossed over to the alternate treatment and repeated the procedure.

The primary endpoint was mean SaO2 for the entire night. The findings revealed that there was no statistically significant difference in SaO2 for the entire night observed among the patients treated with ramelteon compared to placebo (92.2 vs. 92.4%, P=0.576). Additional results showed: People with COPD have few options for treating insomnia because the traditional sleep medications cause a sedative effect that can further depress respiration. "This study is important in helping us understand the effects of ramelteon in patients with moderate to severe COPD," said Louis J. Mini, MD, medical director, Neuroscience, Takeda Pharmaceuticals North America, Inc. "COPD is a common disorder seen in clinical practice, and studies of this type provide useful information for physicians treating this population."
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About ROZEREM

Ramelteon 8 mg is currently marketed as ROZEREM™. ROZEREM 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 targets MT1 and MT2 receptors. The activity at MT1 and MT2 receptors in the suprachiasmatic nucleus (SCN) is thought to promote sleep.

*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 or in children or adolescents. The effects in these populations are unknown. Avoid taking ROZEREM with alcohol. Studies for severe COPD have not yet been evaluated by the FDA. ROZEREM has been associated with decreased testosterone levels and increased prolactin levels. Health professionals should be mindful of any unexplained symptoms which could include cessation of menses or galactorrhea in females, decreased libido or problems with fertility that are 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.

Ketchum UK

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