MELBOURNE, March 30 (UPI) — Officials of the Australian drug maker Biota Holdings ltd. said a Phase II clinical trial of an antiviral treated colds in people with asthma.

Peter Cook, chief executive officer of Biota, said the successful completion of the Phase II trial delivered a major milestone in the development of BTA798, or vapendavir, for the treatment of naturally acquired human rhinovirus — the predominant cause of the common cold — infection in asthmatics.

Drug treatment resulted in a statistically significant reduction in cold symptoms compared to a placebo, Cook said.

Cook said the next phase is to design appropriate Phase III studies.

The Phase II multicenter, randomized, double-blind, placebo-controlled study in asthmatic adults with symptomatic, naturally acquired human rhinovirus infection was conducted over two consecutive seasons in 48 centers in the United States. Subjects received either 400 milligrams of BTA798 or placebo twice daily for six days.

“This trial not only represents a valuable step in the successful delivery of one of Biota’s key programs but it is also a unique accomplishment in the field of antiviral development,” Cook said in a statement. “While the clinical link between human rhinovirus infection and loss of asthma control is now widely accepted, Biota is the first company to evaluate the use of an anti-viral to treat the infection in asthmatics. This has the potential to be of considerable benefit to sufferers through better control of their asthma.”

ROME — In a clinical trial that dramatically confirmed years of observation, early use of antiretroviral therapy reduced the risk of transmitting HIV between couples. the approach also reduces the risk of clinical symptoms of HIV infection, although not to the same degree, according to Myron Cohen, MD, of the University of North Carolina Chapel Hill, and colleagues. the findings support the use of antiretroviral therapy as a public health measure to slow the rate of HIV transmission, Cohen and colleagues reported online in the new England Journal of Medicine and at the International AIDS Society conference here.Action Points  

• Explain that in a clinical trial that dramatically confirmed years of observation, early use of antiretroviral therapy reduced the risk of transmitting HIV between couples.
• Note that the approach also reduces the risk of clinical symptoms of HIV infection.

“The study demonstrates a terrific benefit from earlier therapy,” Cohen told MedPage Today. “It’s quite simple – there’s a clinical benefit for the patient and a dramatic, nearly 100%, reduction in transmission.”

The key question now, he added, is how to best use the knowledge to slow the progress of the HIV/AIDS pandemic.

That’s especially true because “we don’t have enough resources” to treat all those for whom therapy is clinically indicated, according to Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

“With the resources we have, we can’t do everything,” he said, so the question is how to use the findings to have the most impact.

Sustained suppression of HIV in genital secretions is the “most likely” explanation for the reduction in transmission observed in the HIV Prevention Trials Network (HPTN) 052 study, Cohen and colleagues concluded.

The HPTN 052 trial enrolled 1,763 couples, in nine countries, in which one partner was HIV–positive and the other was not. the HIV-positive partners all had relatively robust immune systems and antiretroviral therapy was not indicated according to guidelines.

The HIV-positive partners were randomly assigned to get triple-drug antiretroviral therapy or to wait until the treatment was indicated, with the hypothesis that members of the early-treatment group would be less likely to transmit the virus to their uninfected partners.

A clinical hypothesis was that those getting early treatment would also have a lower risk of serious HIV symptoms: Pulmonary tuberculosis, severe bacterial infection, a World Health Organization stage 4 event, or death.

The HTPN 052 trial was designed with enough statistical power to show a 20% reduction in the risk of transmission, but it was stopped early when an interim analysis showed the risk reduction was 96%, Cohen and colleagues reported.

Indeed, of the 28 transmissions that were genetically linked to the infected partner, only one took place in the early-treatment group (HR 0.04, 9% CI 0.01 to 0.27, P<0.001), they found.

There were 39 cases of HIV transmission, including 11 that could not be linked to the infected partner, the researchers reported. of those, only four were in the early treatment group. the hazard ratio was 0.11 with a 95% confidence interval from 0.04 to 0.32, which was again significant at P<0.001.

Cohen told reporters that the single case of transmission was at best equivocal: the initially uninfected partner was shown to have acquired HIV 85 days after her partner began therapy, but genetic analysis suggested she had been infected more than 50 days and as much as 84 days earlier.

“Our interpretation is that it’s very likely that transmission took place before her partner had enough antiviral to suppress viremia,” Cohen said.

There was also a benefit of early treatment in terms of the primary clinical endpoints, Cohen and colleagues reported. There were 40 such events in the early-therapy group and 65 in the delayed-therapy group (HR 0.59, 95% CI 0.40 to 0.88, P=0.01).

The difference was mainly driven by the incidence of extrapulmonary tuberculosis, seen in three participants in the early-therapy group and 17 in the delayed-therapy group, a difference that was significant at P=0.002.

There was no significant difference between the groups in incidence of pulmonary tuberculosis, they found.

The researchers also reported:

• 82% of the 28 linked transmissions took place in Africa.
• In 18 of the 27 cases in the delayed-treatment group, the source of HIV was a woman; the source of the sole transmission in the early-treatment group was a man.
• 55% of the cases of extrapulmonary tuberculosis were seen in India.
• 97% of the couples were heterosexual and 94% were married.
• 50% of HIV-positive participants were men.
• There were 23 deaths, including 10 in the early-therapy group and 13 in the delayed-therapy group, a difference that was not significant.

Aside from the primary clinical endpoints, 246 HIV-positive participants had one or more severe or life-threatening adverse events, but there was no significant difference between the groups.

The report comes as a series of recent results, including the HPTN 052 trial, has provided “strong encouragement” for the use of antiretroviral drugs to prevent HIV infection, according to Scott Hammer, MD, of Columbia University in new York City.

They include the use of a microbicide gel, containing an anti-HIV drug, to reduce the risk of women acquiring the virus, and a study of oral prophylaxis to prevent infection among men who have sex with men, Hammer noted.

HPTN 052 suggests that there is a “dovetailing of individual and public health benefits” that supports such approaches, Hammer argued in an accompanying editorial in the journal.

But drug therapy as prevention “is not the ultimate answer to controlling and ending the HIV epidemic,” he argued, because of such concerns as adverse events, the possible emergence of drug-resistance, and cost.

Nonetheless, Hammer concluded, such an approach has the “potential to preserve health and control the epidemic until a safe and effective HIV vaccine is a reality.”

The study was supported by the HIV Prevention Trials Network and the National Institute of Allergy and Infectious Diseases. Study drugs were donated by Abbott Laboratories, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, and Merck.

The journal said Cohen did not report any disclosures.

The journal said Hammer reported financial links with Merck and Progenics.

BOOSTER SHOTS: Oddities, musings and news from the health world Asthma pills may work just as well as inhalers in the real world Oral drugs may be as effective as inhaled drugs in relieving asthma symptoms because they are easier to take, suggests a new study. Asthma pills appear to work just as well as inhaled steroids at relieving asthma symptoms in real-life settings, researchers have found, apparently because people prefer swallowing a pill to sticking something up their nose. in one clinical trial, asthma sufferers who took as a first-line therapy the oral medications Singulair or Accolate, each a brand of leukotriene-receptor antagonists, reported as much symptom relief on a quality-of-life survey at two months as those who used an inhaled glucocorticoid, according to a new study published in the new England Journal of Medicine. in a separate trial, patients added one of those drugs or a different type of drug, called a long-acting beta agonist (also an inhaled medication), to their usual regimen of inhaled steroids. again, after two months the researchers found no difference in the regimens’ effectiveness. two years later, the results were similar, researchers noted, if not quite equivalent. even though inhalers have outperformed oral drugs in randomized, controlled studies, the new research compared the two in a more real-world setting: The 650 enrolled patients (ages 12 to 80) were followed for two years, not weeks, and they were responsible for getting their own medications and taking them on schedule. about 65% of patients who took oral drugs as a first-line defense, and 74% who took them as an add-on, stuck with their therapy, compared, respectively, to 41% of those who used an inhaler as a first-line defense and 46% of those who used the beta agonist as an add-on.  An accompanying editorial by two doctors from the Karolinska Institutet in Sweden nicely sums up a possible explanation: “we think this alternative approach works in the real-world setting primarily because it is easier to take a pill once or twice a day than to use an inhaler.” of course, asthma symptoms vary by person, and some treatments work better than others. The Mayo Clinic has a run-down on asthma medications. more study is needed, as the researchers point out. but for some patients it appears that pills may be an option that ultimately helps them to better control their asthma. RELATED: With asthma rates on the rise, here’s how to control symptoms.

Posted in Health | Other Resources

Time: Thursday, May 5th, 2011 at 16:48

April 08, 2011 08:00 AM Eastern Daylight Time 

EWING, N.J.–(BUSINESS WIRE)–Antares Pharma, Inc. (NYSE Amex: AIS) today announced the new Drug Application (NDA) for Anturol® Gel in patients with overactive bladder (OAB) was accepted for filing for review by the U.S. Food and Drug Administration (FDA). Anturol is an oxybutynin gel incorporating Antares’ ATD Gel technology.

“The FDA’s acceptance of the NDA filing is an important milestone in the review process to secure approval from the FDA for commercial distribution of Anturol. We look forward to working with the FDA in their ongoing review of Anturol”

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 8, 2011, ten months from the official NDA filing. The PDUFA date is the target date for the FDA to complete its review of the NDA.

“The FDA’s acceptance of the NDA filing is an important milestone in the review process to secure approval from the FDA for commercial distribution of Anturol. We look forward to working with the FDA in their ongoing review of Anturol,” said Kaushik J. Dave R.Ph., Ph. D., MBA, Senior VP Product Development of Antares Pharma.

The Anturol NDA submission is supported by data from a Phase 3 randomized, double-blind, placebo-controlled clinical trial involving 600 patients with OAB. In the 12-week study, patients treated with Anturol 56 mg daily or 84 mg daily experienced a significant decrease in OAB symptoms versus placebo, including the number of urinary incontinence episodes per day. Anturol was well tolerated in the study with no reported serious treatment-related adverse events. Anticholinergic side effects such as dry mouth and constipation were low and no increase in CNS side effects was seen compared to placebo. The study was conducted under a Special Protocol Assessment (SPA) by the FDA.

“The FDA’s acceptance for filing of the NDA for Anturol, Antares Pharma’s first NDA, is another notable achievement for the Company resulting from the dedicated efforts of the entire Antares team. this is an important accomplishment in the continued execution of our product focused strategy,” said Paul K. Wotton Ph.D., President and Chief Executive Officer.

About Anturol®

Anturol is an oxybutynin gel based on the ATD Gel technology platform which is a clear, odorless, hydroalcoholic gel that provides for delivery of oxybutynin in a non-patch transdermal form. The ATD technology is also used in Elestrin®, an FDA approved product for hormone replacement therapy in postmenopausal women. it has been well recognized that transdermal delivery of drugs including oxybutynin is a safe and effective way of delivering certain drugs that undergo first pass metabolism. By delivering oxybutynin transdermally, first-pass gastric and hepatic metabolism is avoided, which is believed to result in lower anticholinergic side effects such as dry mouth and constipation compared to orally administered treatments. These side effects are believed to account for a significant level of patient non-compliance among existing oral OAB treatments.

About Overactive Bladder

OAB, also called urge incontinence, is a condition marked by a sudden need to urinate that can happen at any time whether or not the bladder is full. OAB is typically caused when the smooth muscle of the bladder undergoes involuntary contractions and may result in uncontrolled leakage. OAB is defined as urgency, with or without urge incontinence and usually includes frequency and nocturia (waking up one or more times during the night to urinate). According to published reports it is estimated that more than 30 million Americans have OAB, and while it can happen at any age is more prevalent among older individuals. it is more common than both diabetes and asthma. According to IMS the annual OAB prescription market in the United States is valued at approximately $2.0 billion.

About Antares Pharma

Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines. The Company’s subcutaneous and intramuscular injection technology platforms include VibexTM disposable pressure-assisted auto injectors, ValeoTM/VisionTM reusable needle-free injectors, and disposable multi-use pen injectors. In the injector area, Antares Pharma has a multi-product deal with Teva Pharmaceutical Industries, ltd that includes Tev-Tropin® human growth hormone and a partnership with Ferring Pharmaceuticals. In the gel-based area, the Company’s lead product candidate is Anturol®, an oxybutynin ATD™ gel that is currently under review by FDA for the treatment of OAB (overactive bladder). Antares also has a partnership with BioSante that includes LibiGel® (transdermal testosterone gel) in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin® (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the U.S. Antares Pharma has corporate headquarters in Ewing, new Jersey, with subsidiaries performing research, development and product commercialization activities in Minneapolis, Minnesota and Muttenz, Switzerland.

Safe Harbor Statement

this press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. such forward-looking statements include statements related to the potential success or failure of the Anturol NDA. such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others, difficulties or delays in the initiation, progress, or completion of product development, clinical trials, and whether or not the Company’s NDA for Anturol is approved by the FDA or any other regulatory authority, including whether the FDA will complete its review of the NDA by December 8, 2011. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2010, and in the Company’s other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. all forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

STORY HIGHLIGHTS

• Graded exercise therapy and cognitive behavior therapy bested adaptive pacing
• Study lasted 52 weeks and included 640 participants
• Treatments are called "effective," but their impact "moderate"

(CNN) — British researchers reported Friday that two controversial treatments for chronic fatigue syndrome appear to be more effective than a third, more commonly accepted treatment, and none of them appears to be linked to major safety problems.

In the clinical trial, whose results were published in the British journal The Lancet, 640 patients with CFS were randomized to one of four treatment groups. for 52 weeks, all of them got specialist medical care.

A quarter of them got nothing more than that; a quarter also got cognitive behavior therapy; another quarter also got graded exercise therapy; and the final quarter also got adaptive pacing therapy.

The study was carried out because previous trials supporting cognitive behavior therapy and graded exercise therapy were small and controversial: Two British patients’ organizations had surveyed their members and concluded the interventions were not only ineffective, but were harmful, said Dr. Michael Sharpe, professor of psychological medicine at the University of Edinburgh and one of the study’s authors.

As an alternative, he told reporters in a news conference posted on the internet, the patient groups were expressing a preference for CFS patients to see specialists and undergo another intervention, called adaptive pacing therapy.

The non-rehabilitative pacing treatment helps patients live within the limits imposed by the illness rather than attempting to break through those limits.

It considers CFS to be an organic disease process that cannot be reversed by changing behavior and that leaves patients with a finite amount of energy. Advocates of the treatment urge patients to pace themselves to avoid fatigue. A therapist advises patients on how to prioritize what they do, but urges them not to try to over do it.

The other two therapies push patients to try to overcome the limits of the illness: cognitive behavior therapy considers CFS to be reversible and recommends changes in behavior and cognition to gradually increase physical and mental activity. Advocates of graded exercise therapy seek to help patients gradually increase their energy level by challenging themselves to boost their exercise and other activity.

But the patient groups’ anecdotal conclusions that cognitive behavior therapy and graded exercise therapy were detrimental did not hold up when subjected to the scrutiny of the rigorously designed study, which was carried out at six centers.

Over the course of a year, 59% of the cognitive behavior therapy group and 61% of the graded exercise therapy group improved a given amount for fatigue and physical function versus 42% of the adaptive pacing therapy group and 45% of the the group that got only specialist medical care.

There was no statistical difference among the groups in serious adverse reactions, which ranged from 1% to 2%.

"We suggest that these findings show that either CBT(cognitive behavior therapy) or GET (graded exercise therapy), when added to SMC (specialist medical care), is an effective treatment for chronic fatigue syndrome, and the size of this effect is moderate," the authors wrote.

"This is something which has a useful effect for a substantial proportion of the people, but it’s clearly not the final solution to the illness," Sharpe said.

The need for reliable treatment data is undisputed. in Britain, CFS is estimated to affect about 250,000 people. Symptoms typically include severe fatigue so disabling that it prevents patients from leading normal lives. It is commonly also associated with difficulties in concentration and memory as well as other symptoms, such as disturbed sleep and widespread pain.

"If people are left untreated, the prognosis is very poor," said Professor Trudie Chalder, professor of cognitive behavioral therapy at Kings College London and another author of the study.

Fewer than 10% of patients recover without treatment, said Sharpe.

The British government was the primary funder of the study, which had limitations, since it excluded patients who were too sick to get to the hospital, the authors acknowledged. in addition, they noted, measurement of outcomes was subjective.

Though the trial shows that recovery from CFS is possible, "there is clearly room for improvement with both interventions," wrote researchers Sijs Bleijenberg and Hans Knoop of the Expert Centre for Chronic Fatigue at Radbourd University Nijmegen Medical Center in the Netherlands.

In an accompanying commentary, they called for more work to come up with better interventions.

The president and CEO of the Chronic Fatigue and Immune Dysfunction Syndrome Association of America, Kim McCleary, said the study focused on treatments that many in the United States have no access to.

"I think it would be challenging, at least in the U.S. system, to purchase the services that they’ve tested in this trial," she told CNN in a telephone interview.

The alphabet soup of acronyms that represent the interventions used in Britain is "just not something that our health care service offers, is reimbursable, or is really available here," McCleary said.

The report comes as researchers have been making progress on the possible role of viruses in causing the disease, she noted. "It’s kind of a shame that we’re still limited to talking about approaches to coping mechanisms as the only therapy that’s available," she said.

A 2007 study by the Centers for Disease Control estimated that approximately 2.5% of the adult population of Georgia suffers from CFS.

McCleary said national estimates put the number of Americans with CFS at 1 million to 4 million.

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Weakened smallpox vaccine shown safe, effective in those with eczemaBavarian Nordic of Denmark announced yesterday that its non-replicating smallpox vaccine Imvamune was safe and effective in people with a skin disorder that places them at increased risk of severe side effects from traditional replicating smallpox vaccines. the conventional smallpox vaccine that makes up most of the US stockpile uses live vaccinia virus, which is related to the smallpox virus and can cause rare but potentially life-threatening side effects. In the phase 2 clinical trial of Imvamune, 350 people who had mild to moderate eczema (atopic dermatitis) and 282 healthy subjects had strong vaccinia-specific immune responses and good tolerance profiles after vaccination, according to a company press release. "the data from this trial strongly suggest that Imvamune is suitable for individuals with atopic dermatitis," said Bavarian Nordic President and CEO Anders Hedegaard. "With these results, the government can and should take the next step of expanding the population it protects with this vaccine." the release did not specify how immune response was measured or the number and type of adverse events. the US government has stockpiled 20 million doses of Imvamune for people with immune deficiencies, such as those with HIV.Feb 1 Bavarian Nordic press release

Cholera reported in Canada, possible case cited in US deporteeA Canadian woman was treated for cholera at a Montreal hospital after spending time in Haiti, while a Haitian man who was deported from the United States died of a cholera-like illness in a jail in his home country, according to news reports today. Lucie Dufresne, a spokeswoman for the University of Montreal Hospital Centre, said a cholera patient was admitted on new Year’s Day and received antibiotics and rehydration therapy during her 2-day stay, according to a Canadian Press (CP) report. the case is the only one in Quebec since the start of the Haitian epidemic, Dufresne said. meanwhile, the Associated Press (AP) reported that a Haitian who was among the first US detainees to be deported to Haiti since the January 2010 earthquake died after suffering cholera-like symptoms. Wildrick Guerrier, 34, was deported to Haiti on Jan 20 with 26 others, all but one of whom had been convicted of a crime in the United States, the story said. Immigration advocates said Guerrier was healthy before he was confined in a cell with 17 other men, according to the story. He was released to his aunt’s care Jan 27 but died on Jan 29. Michelle Karshan of Alternative Chance, a group that works with criminal deportees to Haiti, said at least one other deportee is now suffering from cholera-like symptoms in Haiti, according to the report.Feb 2 CP storyFeb 2 AP story

On Thursday January 20, 2011, 11:20 am EST

NEW YORK (AP) — Forest Laboratories Inc. said Thursday its depression treatment levomilnacipran failed in a late-stage clinical trial, as the drug was no more effective than a placebo at treating depression.

Forest and its partner, French drugmaker Pierre Fabre Medicament, said the patients treated with levomilnacipran and patients treated with placebo had similar results, and the difference between them was not statistically significant. in the trial, 362 patients were treated with 40 milligrams to 100 milligrams of levomilnacipran per day or a placebo. The 11-week study compared the change in patients’ symptoms on a clinical rating scale.

The companies said 8 percent of the levomilnacipran patients left the study due to side effects, compared to 2.2 percent of patients who took the placebo. The most common side effects of treatment with levomilnacipran were nausea and headache. Forest and Pierre Fabre are running two other late-stage trials of the drug, and they expect results from those studies in the second half of 2011.

Shares of Forest fell 30 cents to $31.58 in morning trading.

Roche Holding, AG, a major pharmaceutical company, has released results of an eight-week phase II clinical trial for a schizophrenia drug it has tentatively named RG1678. According to a report by the Wall Street Journal online, volunteers who took the drug plus a second-generation FDA-approved antipsychotic experienced a significant reduction in the negative symptoms of schizophrenia. Negative symptoms include lack of interest, lack of motivation and social isolation to the point that work is not possible. no currently approved drugs treat the negative behavioral symptoms of schizophrenia.

The researcher administered several different drug dosages during the trial and found that the 10 mg and 30 mg doses were more effective than the 60 mg doses. According to the article, the drug has a good safety profile and is generally well-tolerated.

A stage III clinical trial is currently underway. if RG1678 performs well in this trial, which involves a larger number of volunteers being tested for a longer period of time, it could be approved and available for use in 2013 or 2014. Meanwhile, schizophrenia drugs that treat the positive symptoms are available, lessening the effects of delusions and hallucinations in symptomatic patients. Monitor this website and other news outlets for future results regarding RG1678.

Read more: online.wsj.com/article/BT-CO-20101206-703306.html

Ask a doctor or pharmacist.

Anxiety and panic causes stress and this brings on short term memory loss. you need to see your doctor, he can give you something for the panic attacks, as to restoring your memory loss, I am not sure there is anything that will help with this.

For every child, treatment may vary, what may be a wonder drug for one child may be a complete disaster for another, and sometimes meds used off label (i.e., they weren't intended to treat anxiety/panic) may work as well. it is important that you work with a medical professional when using medications for treatment and creating a treatment plan.

You may want to follow the research on a medication that is currently in trial at this time, STX209, clinical trial is going on for Autism and Fragile X, the study med is based on Baclofen, a med that has been on the market for years and is available. We've participated in the clinical trial and the medication did much more than just treat irritability, my child was in school during the time he was on the study medication and he improved in eleven different areas on his progress report.

Also, there is a new drug that will come to clinical trials in 2010 that in the animal model reversed symptoms and improved cognitive ability, see details below from an article in Time Magazine for more information and for more technical information visit Seaside Therapeutics.

I also encourage you to follow the research from Seaside Therapeutics, treatment options for autism and fragile X are rapidly changing.

Marijuana

Black Coffee.

Possibly St John's Wort. A very judicious use of anti-anxiety herbs– they can have a rebound effect that would be worse than the original panic. this is why people recommend doctors; any herb/drug that helps may hurt if not used VERY carefully.

I don't know any specific medication but I do know a book which can help people deal with Autism. Not only that, it also gives you information on what it is and how to deal with it. My niece was diagnosed with autism when she was 6 and it's been really difficult for her family. They said they have started reading this book and it made their lives a bit easier. I hope this book can help you too.