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Births To Unmarried Women Increasing In U.S., Driven By Women In 20s, 30s, Report Shows
Almost 40% of U.S. births in 2007 occurred among unmarried women, according to a report from the Centers for Disease Control and Prevention"s National Center for Health Statistics, the Washington Post reports. About 1.7 million infants were born to unmarried women in 2007, representing a 26% increase over the 1.4 million in 2002 and more than double the number in 1980. Unmarried women accounted for 39.7% of all U.S. births in 2007, up from 34% in 2002 and more than double the percentage in 1980, according to the report, which studied birth certificates nationwide.Women in their 20s and 30s are the biggest drivers of the trend, with out-of-wedlock births in this age group increasing from a rate of 13% to 34% between 2002 and 2006, according to the report (Stein/St. George, Washington Post, 5/14). For example, the birthrate for unmarried women ages 30 to 34 rose by 34% in 2007 compared with 2002 (Harris, New York Times, 5/14). Sixty percent of births to women ages 20 to 24 were to unmarried women, compared to 52% in 2002. In addition, 32% of births to women 25 to 29 were to unmarried women, compared to 25% in 2002, the report shows (Jayson, USA Today, 5/14). Overall, women in their 20s made up 60% of U.S. unmarried births in 2007, while teens accounted for 23% and women ages 30 and older accounted for 17% (New York Times, 5/13). Unmarried Hispanic women gave birth at a rate of 106 births per 1,000 unmarried women. The rate was 72 per 1,000 for blacks, 32 per 1,000 for whites and 26 per 1,000 for Asians. The rates for blacks and Hispanics rose the fastest, according to the report (Washington Post, 5/14). Compared with other countries, the U.S. rate of unmarried births was near the middle of the 14 countries included in the report (USA Today, 5/14).Although researchers did research the reasons for the trend, they cited several factors that in combination likely affected the rate, including a decrease in the social stigma surrounding out-of-wedlock births, an increasing number of couples putting off or forgoing marriage, and growing numbers of financially independent, older or single women who choose to have children on their own (Washington Post, 5/14). Researchers noted that most of the increase in these births was among parents who live together but are not married (New York Times, 5/13)."I think this is the tipping point," Rosanna Hertz of Wellesley College said, adding, "This is becoming increasingly the norm. The old adage that "first comes love, then comes marriage, then comes baby in the baby carriage" just no longer holds true." Hertz added, "Women can have children on their own, and it"s not going to destroy your employment, and it"s not going to mean that you"ll be made a pariah by the community. It"s much more socially acceptable." Sarah Brown of the National Campaign To Prevent Teen and Unplanned Pregnancy said, "I look at this and say, maybe this trend is what young adults want or stumble into, but it"s not in the best interest of children" (Washington Post, 5/14).
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Alkermes Initiates Two New Clinical Trials Of ALKS 33

Alkermes, Inc. (NASDAQ: ALKS) announced the initiation of two new clinical trials of ALKS 33, an oral opioid modulator for the potential treatment of addiction and other nervous system disorders. Study ALK33-004 is a phase 1 clinical trial designed to examine the ability of ALKS 33 to block the effects of an opioid following a single oral dose of ALKS 33 in healthy, non-dependent, opioid-experienced subjects. Study ALK33-003 is a phase 1 clinical trial designed to evaluate the pharmacokinetics, safety and tolerability of multiple doses of ALKS 33 in healthy volunteers. The initiation of these studies follows the successful completion of a phase 1 dose escalation study of ALKS 33 in healthy volunteers. Alkermes expects to report data from both ALK33-004 and ALK33-003 in the second half of calendar 2009. "ALKS 33 is an excellent example of how Alkermes is leveraging its new insights about opioid receptor pathways to develop medications with unique advantages over currently available therapies," stated Elliot Ehrich, M.D., chief medical officer at Alkermes. "We expect to use the data from these additional phase 1 studies to shape our plans for phase 2 clinical development." ALKS 33 Study Designs ALK33-004 is a phase 1, randomized, single-blind, placebo-controlled, single-dose study designed to test the ability of ALKS 33 to block the effects of an opioid agonist, remifentanil, a commercially available analgesic. Approximately 24 healthy, non-dependent, opioid-experienced subjects will be randomized to receive a placebo dose as well as one of two dose levels of ALKS 33. The ability of ALKS 33 to block the effects of remifentanil will be measured by pupillometry assessments and subjective measures of opioid effects. The pharmacokinetics and safety of ALKS 33 will also be evaluated. ALK33-003 is a phase 1 randomized, double-blind, placebo-controlled, multi-dose study designed to assess the steady-state pharmacokinetics, safety and tolerability of ALKS 33. Approximately 30 healthy subjects will be randomized to receive seven consecutive, daily oral doses of one of two dose levels of ALKS 33 or placebo. About ALKS 33 ALKS 33 is an oral opioid modulator that builds on Alkermes" scientific expertise in brain reward pathways as well as the company"s clinical and commercial knowledge in the field of addiction. In April 2009, Alkermes presented topline data from a phase 1 randomized, double-blind, placebo-controlled study of ALKS 33 in 16 healthy volunteers. Data from the study showed that ALKS 33 was generally well tolerated and demonstrated rapid oral absorption, high plasma concentrations and duration of action that supports once daily dosing. The study results are consistent with previous findings that ALKS 33 is not metabolized by the liver, a unique advantage over existing oral therapies for addiction. About Opioid Receptor Pathways Opioid receptor pathways have biological activity throughout the body including the brain, gastrointestinal system, immune system and cardiovascular system. Consequently, opioid receptor pathways play a key role in a broad range of nervous system disorders such as pain, addiction, psychiatric disorders, gastrointestinal disorders and immune disorders. Opioid modulators can act as agonists, antagonists or partial agonists at opioid receptors throughout the body. Emerging biological research and new medicinal chemistry insights now allow for the development of novel opioid modulators with the potential to show enhanced activity at opioid receptor sites and could ultimately lead to improved therapeutic options. Alkermes


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