Showing posts sorted by date for query amantadine. Sort by relevance Show all posts
Showing posts sorted by date for query amantadine. Sort by relevance Show all posts

Friday, February 1, 2019

New One-Dose Flu Drug Shows Promise

An experimental single-dose flu drug shows promise as a new way to alleviate the misery of influenza, researchers say. 

Baloxavir marboxil.svg
The drug  called baloxavir (structre)  worked better than no treatment in one phase of a new study. The study also found it as effective as the current standard drug, oseltamivir (Tamiflu), at controlling symptoms such as coughing, sore throat, headache, fever, muscle and joint pain, and fatigue.
Moreover, in light of concerns about flu-drug resistance, most patients treated with baloxavir responded as expected, the study authors said.
"There are few approved influenza antivirals, and current treatments have limitations," said study lead author Dr. Frederick Hayden, of the University of Virginia School of Medicine.
"For example, currently circulating influenza viruses are resistant to the older class of antivirals," he said. These include the drugs amantadine (brand name Symmetrel) and rimantadine (Flumadine).
Resistance is also growing to the class of drugs including widely used Tamiflu and Relenza (zanamivir), Hayden said. "Consequently, there are medical needs for new anti-influenza agents with different mechanisms of action and greater potency," he added.
Hayden, professor emeritus of clinical virology and medicine, said the new study indicates that baloxavir resolves flu symptoms as quickly, effectively and safely as current options, without yet raising concerns about resistance. It also demonstrated "significantly greater antiviral effects," he added.
Also, while Tamiflu must be taken twice a day for five days, baloxavir requires just one dose.
The investigation was funded by the drug company Shionogi, Inc., which developed and manufactures baloxavir.
Baloxavir is approved for use in Japan. In the United States, it remains an "investigational drug," with the U.S. Food and Drug Administration expected to decide on approval by the end of this year.
The new study, which was published Sept. 6 in the New England Journal of Medicine, unfolded in two trials, both involving otherwise healthy flu patients at low risk for influenza complications.
One trial was conducted during the 2015-2016 flu season. About 400 patients, aged 20 to 64, received one of three doses of baloxavir (ranging from 10 to 40 milligrams) or a placebo. Flu symptoms eased notably faster among all three baloxavir groups, compared with placebo (untreated) patients, the findings showed.
The following flu season, nearly 1,100 patients, aged 12 to 64, were treated with baloxavir or Tamiflu. The drugs relieved symptoms in roughly the same time period, with similar side-effect risk.
However, about 10 percent of the baloxavir patients had a less than robust response to the drug. Hayden acknowledged that "the clinical and public health implications of reduced susceptibility to baloxavir are not fully understood."
Dr. Timothy Uyeki, author of an accompanying journal editorial, heads the influenza division at the U.S. Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases.
"There is a need for antiviral drugs with new mechanisms of action," he agreed.Uyeki highlighted the benefit of baloxavir's single-dose regimen. Besides its convenience, it "avoids concerns about compliance with a five-day treatment course of oseltamivir," he said.
But he also stressed the need for further testing.
It remains unclear what benefits might accrue from combining baloxavir with Tamiflu, Uyeki noted.
Also, he cautioned, the current research only included otherwise healthy people aged 12 to 64 who were not at high risk for flu complications. Whether baloxavir will benefit high-risk groups -- young children, the elderly, pregnant women and others with underlying chronic medical conditions -- remains unknown, Uyeki said.
"A lot more studies are needed of the clinical benefit of baloxavir treatment of influenza in high-risk outpatients," he added.

Thursday, April 19, 2018

FDA Approves Osmolex ER (amantadine) for the treatment of Parkinson’s Disease and Drug-Induced Extrapyramidal Reactions


In continuation of my update on amantadine

Osmotica Pharmaceutical US LLC, announced the  U.S. Food and Drug Administration (FDA) has approval Osmolex ER, an amantadine extended release tablet, for the treatment of Parkinson's disease and for the treatment of drug-induced extrapyramidal reactions in adult patients. Extrapyramidal symptoms are known side effects of many common medications.

“The FDA’s approval of Osmolex ER provides a new treatment option for those patients suffering from Parkinson’s disease and adults who have extrapyramidal reactions, or movement disorders, that are caused by certain medicines. We are eager to make Osmolex ER available to physicians and patients in the U.S.,” stated Brian Markison, Chief Executive Officer of Osmotica.
“We are currently finalizing our plans to commercialize the product and ensure patients and providers have access as soon as possible. We believe that the approved indications and compelling value proposition will be important factors in physician adoption and marketing of Osmolex ER,” added Markison.
Osmolex ER tablets, a proprietary drug formulation containing a combination of immediate release and extended release amantadine utilizing Osmotica’s patented Osmodex® technology, represents a new once-a-day approach to the treatment of Parkinson’s disease and drug-induced involuntary movements in adults. The Osmolex ER tablet is taken once-daily in the morning, releasing amantadine throughout the day. Physicians have three dosage options with 129 mg, 193 mg and 258 mg tablets, with a maximum daily dose of 322 mg, providing them with dosing flexibility for each patient.
Osmolex ER is protected by three formulation patents with protection extending through March 2030, with additional patent applications pending.

Tuesday, December 29, 2009

Gren tea for new type of H1N1 Flu ......

In continuatation of my update on Epigallocatechin gallate (EGCg), I find this info something different and interesting too. We are aware about the antioxidant and anticancer activities of this compound, but now researchers from Central Research Institute of ITO EN, Ltd., & School of Pharmaceutical Sciences, University of Shizuoka have found the same compound to inhibits flu infection. As per the researchers claim, the compound had an inhibitory effect against three types of influenza viruses, including the swine-origin H1N1 virus that caused pandemic flu in 2009, and that its effect did not depend on the type of virus. These findings once again suggest that green tea is effective in preventing flu.

Gargling with green tea has already proved to prevent the onset of seasonal flu. It has become clear that catechin, a major type of polyphenol in green tea, plays a major role in prevention of flu infection, and that, among different types of catechin, EGCg displays the strongest antiviral activity. More interestingly, the researchers have conducted examinations to see if EGCg also shows antiviral activity against the new type of H1N1 virus, regardless of viral subtypes.

Solutions containing three types of viruses including the H1N1 virus were mixed with EGCg extracted from green tea. The mixture was added to cultured cells, which were thus infected. The cells were incubated for a set period of time, and the number of infected cells was counted. The concentration of EGCg at which virus infection was inhibited to 50% of the level of infection without EGCg was calculated.

The experiments showed that EGCg prevented flu virus infections at lower concentrations than Amantadine (a drug used to prevent and treat flu). A typical concentration of EGCg in green tea infused from a teapot is reported as 5,000-7,000 micromoles/L. Therefore, these results indicate that green tea diluted 1,000-fold or more is effective to halve infections by three types of viruses, including H1N1.

Those interested to know the details about green tea can visit the site.

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Friday, October 30, 2009

Triple-combo Drug for Antiviral-resistant H1N1 ?

In laboratory testing, the triple combination of oseltamivir (Tamiflu), amantadine (Symmetrel) and ribavirin showed a significant capacity to stop flu-virus growth, says Mark Prichard....