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Second U.S. Independent Laboratory Confirms That Oculus Innovative Sciences' Microcyn(R) Technology Effective At Inactivating H1N1 Swine Flu
Oculus Innovative Sciences, Inc. (NASDAQ:OCLS), a healthcare company that develops, manufactures and markets a family of products based upon the Microcyn® Technology platform, which includes new formulations intended to reduce the use of antibiotics by preventing or treating infections including those caused by bacteria and viruses, has confirmed the effectiveness of Microcyn® Technology at inactivating the H1NI Swine Influenza A. In a virucidal time-kill suspension test conducted by an independent laboratory, BioScience Laboratories, Inc., the specific Microcyn Technology formulation reduced infectivity of the swine flu virus by 4.00log10 (99.99%) reduction after just 30-seconds exposure. BioScience Laboratories, working in cooperation with the U.S. Department of Agriculture, received formal approval to acquire, house and evaluate the specific swine influenza virus in April 2009.
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FBI Should Probe Whether 'Systemic Problems' Led To 'Gaps' In Tiller Murder Case, NYT Editorial States
U.S. Attorney General Eric Holder and Congress "should review the killing" of Kansas abortion provider George Tiller "to determine whether there are systemic problems that led to apparent gaps in the FBI"s performance in the case," a New York Times editorial states. According to the Times, Holder "took the prudent step of ordering" the U.S. Marshals Service to "provide security for certain abortion clinics and physicians thought to be at heightened risk," but the government"s response "must not end there."The editorial states that Scott Roeder, the man accused of killing Tiller, has a history of activity related to the antiabortion-rights movement that "should have sparked greater concern" with the FBI, including being suspected in 2000 of "repeatedly gluing shut the doors of an abortion clinic in Kansas City, Kan. -- a federal crime under the 1994 Freedom of Access to Clinic Entrances law." Roeder also was found in possession of "gunpowder and a fuse" when stopped for a traffic violation in 1996, according to the Times. The editorial states, "In the past, Tiller was shot in both arms, and his clinic was bombed and vandalized," but "it seems as if the federal authorities failed to increase security for Dr. Tiller and his offices."The editorial continues, "An armed criminal bent on murder is hard to stop, and we do not blame the FBI for Dr. Tiller"s death." However, "reproductive rights advocates say enforcement of the clinic protection law waned in the Bush years," the editorial says, concluding that Holder "should make sure there is no underlying problem that inhibits efforts to combat intimidation and violence against the dwindling number of legal abortion providers -- and women they help" (New York Times, 6/8).
News of the day
Economic Crisis Heightens Financial Fallout For Bereaved
One in five people fall below the official poverty line following the death of their partner. "Hence the recent fall in the value of annuities, savings and investments means an even wider group of older people could face financial difficulties when their partner dies, whether these difficulties are short-lived or longer lasting," says researcher Anne Corden of the Social Policy Research Unit, University of York
Diagnostics

Vyvanse CII Significantly Improved ADHD Symptoms For Children 13 Hours After Administration

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, has announced that a study published online in the peer-reviewed journal Child and Adolescent Psychiatry and Mental Health found once-daily Vyvanse® (lisdexamfetamine dimesylate) CII significantly reduced the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 12 from the first time point measured (1.5 hours) up to the last time point assessed (13 hours) after administration. In this pediatric analog classroom study, treatment with Vyvanse was associated with significant improvement in behavior and attention in children at each time point measured, with improvement at 13 hours after administration. "Pediatric patients may require ADHD symptom improvement both at school and after school," said Sharon Wigal, PhD, lead investigator of the study, clinical professor of pediatrics and director of clinical trials in the Child Development Center at the University of California, Irvine. "These published data are the first to have shown duration of effect of an oral ADHD stimulant in children aged 6 to 12 at 13 hours after administration. Physicians and caregivers who are seeking a long-acting medication that provides ADHD symptom improvement from morning through homework and family time may want to consider this Vyvanse study data." On May 22, 2009, the US Food and Drug Administration (FDA) approved a change to the prescribing information for Vyvanse to include supplemental data that demonstrated significant ADHD symptom improvement in children aged 6 to 12 from the first time point measured (1.5 hours) up to 13 hours postdose. Vyvanse is now the first and only oral ADHD stimulant treatment to have efficacy at 13 hours after administration for pediatric patients included in its product labeling. "Shire is proud to be at the forefront of ADHD research and treatment development and is committed to providing patients with effective ADHD medications, such as Vyvanse," said Liza Squires, MD, Research and Development Business Unit Leader for Shire. "These findings provided further support that Vyvanse can be an important treatment option for children who require duration of ADHD symptom improvement throughout the day." Vyvanse Demonstrated Significant Symptom Improvement at 13 Hours After Administration The study was a randomized, double-blind, placebo-controlled, analog classroom study that assessed the efficacy and safety of Vyvanse in 129 children aged 6 to 12 years with ADHD. Following a four-week, open-label, dose-optimization phase with Vyvanse at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of Vyvanse the first week and placebo the second week. The second group received placebo the first week and their optimal dose of Vyvanse the second week. The primary objective of this study was to assess the time of onset of Vyvanse compared with placebo, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment (SKAMP-D) rating scale. Secondary objectives included assessment of the duration of efficacy of VYVANSE compared with placebo, as measured by the SKAMP-D scale, and assessment of efficacy and time of onset of Vyvanse compared with placebo as measured by SKAMP Attention (SKAMP-A), and Permanent Product Measure of Performance (PERMP) scales. In the study, Vyvanse demonstrated significant efficacy versus placebo at 1.5 hours, the first time point measured. Further, Vyvanse treatment was associated with significant efficacy as measured by both subjective (SKAMP-D and SKAMP-A) and objective (PERMP) assessments from the first time point (1.5 hours) through the last time point (13 hours) assessed during the classroom day, and at all time points in between (2.5, 5.0, 7.5, 10.0, and 12.0 hours). Safety was also evaluated during the study. The adverse event profile for Vyvanse was similar to other currently marketed stimulants. The most frequently reported adverse events (greater than or equal to 10 percent) in the dose-optimization phase for patients taking Vyvanse were decreased appetite, insomnia, headache, irritability, upper abdominal pain, and affect lability. Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children aged 6 to 12 years and approved in April 2008 to treat ADHD in adults, is currently available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. To date, more than 6 million Vyvanse prescriptions have been filled, bringing the current US market share to over 12 percent based on weekly branded prescription volume. Additionally, Shire has executed agreements with 10 of Shire"s top 11 managed care organizations (MCOs) to cover Vyvanse in a preferred formulary position. Vyvanse is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of Vyvanse to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in GI transit times. Additional information about Vyvanse and Full Prescribing Information, including Medication Guide, are available at http://www.vyvanse.com. Matthew Cabrey Porter Novelli


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