Sanofi-aventis
(Paris Bourse: EURONEXT: SAN; and New York: NYSE: SNY) today announced
results from a study that demonstrated AMBIEN CR is well-tolerated and
effective in improving sleep onset and maintenance for up to six months in
patients with chronic primary insomnia when taken as needed for up to seven
nights per week, without rebound insomnia following discontinuation. These
data are being presented on July 12 in Chicago at the CINP (Collegium
Internationale Neuro- Psychopharmacologicum) 25th Biennial Congress, a
meeting ground for clinicians and scientists to report new scientific
evidence in biochemistry, pharmacology, safety, and therapeutic efficacy of
neuropsychiatric drugs.
According to the data, AMBIEN CR demonstrated significant improvements in total sleep time (TST), sleep onset latency (SOL), wake time after sleep onset (WASO), sleep quality, and number of awakenings versus placebo. AMBIEN CR is the first and only controlled release prescription sleep medicine approved by the FDA for sleep induction and sleep maintenance.
"These data are important for patients who experience chronic insomnia because they demonstrate there is a treatment option in AMBIEN CR that can be taken safely and effectively as needed long-term to help them both fall asleep and maintain sleep through the night," said Tom Roth, PhD, director, Sleep Disorders Center, Henry Ford Hospital.
About the Study
This multicenter, double-blind, placebo-controlled evaluation of AMBIEN CR 12.5mg involved 1,018 adult volunteers who were studied for a period of 25 weeks. The objective of this study was to evaluate the long-term safety and efficacy of AMBIEN CR taken as needed up to 7 nights per week. Efficacy was assessed by Patient Global Impression (PGI) and Clinical Global Impression (CGI) scales every 4th week and daily morning questionnaires. The PGI scale requires patients to rate how much their condition has improved or worsened relative to baseline. The Clinical Global Impression (CGI) scale requires the clinician to rate how much the patient's condition has improved or worsened relative to baseline. The primary endpoint of the study was the 12-week PGI aid to sleep. Rebound insomnia was evaluated the first three nights after treatment discontinuation at the end of the study.
Study Results
In PGI measurements for the AMBIEN CR group at weeks 12 and 24, 89.8% and 92.3% of patients reported that treatment helped them sleep versus 51.4% and 59.7% of patients in the placebo group. From score analysis, AMBIEN CR significantly improved PGI versus placebo at each 4-week interval of the 24- week treatment period (P<.0001, all time points). By CGI, the percentage of patients who reported "much or very much improved" was significantly greater at each 4-week interval of the treatment period (P<.0001, all time points) in the AMBIEN CR group (week 12: 75.0%; week 24: 84.3%) compared with the placebo group, respectively (week 12: 37.1%; week 24: 48.1%). No worsening of TST or WASO, versus baseline, occurred following discontinuation. AMBIEN CR tablet intake was stable across six months (mean treatment days/month across months: range 18.9-20.1).
About Insomnia
Chronic insomnia affects approximately 30 million Americans, according to a 2006 report of the Institute of Medicine Committee (IOM) on Sleep Medicine and Sleep Research. The long-term effects of sleep disorders have been associated with a variety of serious medical conditions.
Insomnia can lead to stress and reduced productivity, and thus may be costly to the workplace. Research shows insomnia can be a predictor of absenteeism. Poor work efficiency has been demonstrated in insomniacs compared to normal sleepers. Chronic and occasional insomniacs were both more likely to doze off during daytime activities or when bored, and to take naps than individuals who do not experience insomnia.
About AMBIEN CR
AMBIEN CR is the first and only controlled-release formula prescription sleep medication approved by the FDA for sleep maintenance in addition to sleep induction. AMBIEN CR is a bi-layered tablet delivered in two stages. The first layer dissolves quickly to induce sleep. The second layer is released more gradually into the body to help provide more continuous sleep.
AMBIEN CR is indicated for treating insomnia. It is a treatment option you and your healthcare professional can consider along with lifestyle changes and can be taken for as long as your healthcare professional recommends. Until you know how AMBIEN CR will affect you, you shouldn't drive or operate machinery. Be sure you're able to devote 7 to 8 hours to sleep before being active again. Side effects may include next-day drowsiness, dizziness and headache. It's non-narcotic; however, like most sleep medicines it has some risk of dependency. Don't take it with alcohol.
For full prescribing information, please visit http://www.AMBIENCR.com and see accompanying prescribing information.
About sanofi-aventis
Sanofi-aventis is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward- Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law, sanofi- aventis does not undertake any obligation to update or revise any forward- looking information or statements.
sanofi-aventis
http://www.sanofi-aventis.com
According to the data, AMBIEN CR demonstrated significant improvements in total sleep time (TST), sleep onset latency (SOL), wake time after sleep onset (WASO), sleep quality, and number of awakenings versus placebo. AMBIEN CR is the first and only controlled release prescription sleep medicine approved by the FDA for sleep induction and sleep maintenance.
"These data are important for patients who experience chronic insomnia because they demonstrate there is a treatment option in AMBIEN CR that can be taken safely and effectively as needed long-term to help them both fall asleep and maintain sleep through the night," said Tom Roth, PhD, director, Sleep Disorders Center, Henry Ford Hospital.
About the Study
This multicenter, double-blind, placebo-controlled evaluation of AMBIEN CR 12.5mg involved 1,018 adult volunteers who were studied for a period of 25 weeks. The objective of this study was to evaluate the long-term safety and efficacy of AMBIEN CR taken as needed up to 7 nights per week. Efficacy was assessed by Patient Global Impression (PGI) and Clinical Global Impression (CGI) scales every 4th week and daily morning questionnaires. The PGI scale requires patients to rate how much their condition has improved or worsened relative to baseline. The Clinical Global Impression (CGI) scale requires the clinician to rate how much the patient's condition has improved or worsened relative to baseline. The primary endpoint of the study was the 12-week PGI aid to sleep. Rebound insomnia was evaluated the first three nights after treatment discontinuation at the end of the study.
Study Results
In PGI measurements for the AMBIEN CR group at weeks 12 and 24, 89.8% and 92.3% of patients reported that treatment helped them sleep versus 51.4% and 59.7% of patients in the placebo group. From score analysis, AMBIEN CR significantly improved PGI versus placebo at each 4-week interval of the 24- week treatment period (P<.0001, all time points). By CGI, the percentage of patients who reported "much or very much improved" was significantly greater at each 4-week interval of the treatment period (P<.0001, all time points) in the AMBIEN CR group (week 12: 75.0%; week 24: 84.3%) compared with the placebo group, respectively (week 12: 37.1%; week 24: 48.1%). No worsening of TST or WASO, versus baseline, occurred following discontinuation. AMBIEN CR tablet intake was stable across six months (mean treatment days/month across months: range 18.9-20.1).
About Insomnia
Chronic insomnia affects approximately 30 million Americans, according to a 2006 report of the Institute of Medicine Committee (IOM) on Sleep Medicine and Sleep Research. The long-term effects of sleep disorders have been associated with a variety of serious medical conditions.
Insomnia can lead to stress and reduced productivity, and thus may be costly to the workplace. Research shows insomnia can be a predictor of absenteeism. Poor work efficiency has been demonstrated in insomniacs compared to normal sleepers. Chronic and occasional insomniacs were both more likely to doze off during daytime activities or when bored, and to take naps than individuals who do not experience insomnia.
About AMBIEN CR
AMBIEN CR is the first and only controlled-release formula prescription sleep medication approved by the FDA for sleep maintenance in addition to sleep induction. AMBIEN CR is a bi-layered tablet delivered in two stages. The first layer dissolves quickly to induce sleep. The second layer is released more gradually into the body to help provide more continuous sleep.
AMBIEN CR is indicated for treating insomnia. It is a treatment option you and your healthcare professional can consider along with lifestyle changes and can be taken for as long as your healthcare professional recommends. Until you know how AMBIEN CR will affect you, you shouldn't drive or operate machinery. Be sure you're able to devote 7 to 8 hours to sleep before being active again. Side effects may include next-day drowsiness, dizziness and headache. It's non-narcotic; however, like most sleep medicines it has some risk of dependency. Don't take it with alcohol.
For full prescribing information, please visit http://www.AMBIENCR.com and see accompanying prescribing information.
About sanofi-aventis
Sanofi-aventis is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward- Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law, sanofi- aventis does not undertake any obligation to update or revise any forward- looking information or statements.
sanofi-aventis
http://www.sanofi-aventis.com
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