Aa
You say tomato I say tomahto! Victrelis?
What's in a name? I don't know but boceprevir changed their name and the way they look I guess. Here's a ton of information if you want to read it all. Victrelis, that's a new one for me, hopefully it's in the drug stores soon!!
Date: Fri, 13 May 2011 16:14:37 -0500 (CDT)
Subject: FDA Hepatitis Update - Approval of VICTRELI (boceprevir) a direct acting antiviral drug to treat hepatitis C virus (HCV)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm255390.htm
FDA approves Victrelis for Hepatitis C
The U.S. Food and Drug Administration today approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.
The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1,500 adult patients. In both trials, two-thirds of patients receiving Victrelis in combination with pegylated interferon and ribavirin experienced a significantly increased sustained virologic response (i.e., the hepatitis C virus was no longer detected in the blood 24 weeks after stopping treatment), compared to pegylated interferon and ribavirin alone, the current standard of care.
When a person sustains a virologic response after completing treatment, this suggests that HCV infection has been cured.
Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocelluar carcinoma), and decreased mortality.
“Victrelis is an important new advance for patients with hepatitis C,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy.”
According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.
Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C virus (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.
People can get the hepatitis C virus in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor, toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.
Victrelis is a pill taken three times a day with food. The therapy is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.
The most commonly reported side effects in patients receiving Victrelis in combination with pegylated interferon and ribavirin include fatigue, low red blood cell count (anemia), nausea, headache and taste distortion (dysgeusia).
Victrelis is marketed by Whitehouse Station, N.J.-based Merck.
For more information:
FDA: Approved Drugs: Questions and Answers
1
FDA: What’s New at FDA in Hepatitis
2
FDA: Hepatitis C Tests
3
CDC: Hepatitis C Information for the Public4
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
#
Visit the FDA on Facebook5
Date: Fri, 13 May 2011 16:14:37 -0500 (CDT)
Subject: FDA Hepatitis Update - Approval of VICTRELI (boceprevir) a direct acting antiviral drug to treat hepatitis C virus (HCV)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm255390.htm
FDA approves Victrelis for Hepatitis C
The U.S. Food and Drug Administration today approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.
The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1,500 adult patients. In both trials, two-thirds of patients receiving Victrelis in combination with pegylated interferon and ribavirin experienced a significantly increased sustained virologic response (i.e., the hepatitis C virus was no longer detected in the blood 24 weeks after stopping treatment), compared to pegylated interferon and ribavirin alone, the current standard of care.
When a person sustains a virologic response after completing treatment, this suggests that HCV infection has been cured.
Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocelluar carcinoma), and decreased mortality.
“Victrelis is an important new advance for patients with hepatitis C,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy.”
According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.
Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C virus (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.
People can get the hepatitis C virus in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor, toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.
Victrelis is a pill taken three times a day with food. The therapy is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.
The most commonly reported side effects in patients receiving Victrelis in combination with pegylated interferon and ribavirin include fatigue, low red blood cell count (anemia), nausea, headache and taste distortion (dysgeusia).
Victrelis is marketed by Whitehouse Station, N.J.-based Merck.
For more information:
FDA: Approved Drugs: Questions and Answers
1
FDA: What’s New at FDA in Hepatitis
2
FDA: Hepatitis C Tests
3
CDC: Hepatitis C Information for the Public4
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
#
Visit the FDA on Facebook5
More to the point of "our" Victrelis and Inciveck
..."Branding specialists proclaim that “z,” “k,” “c,” and “g” sound strong and reliable. They assert that plosives like “p,” “t,” “k,” and “c” are powerful-sounding, whereas “l,” “r,” and “s” are calming and relaxing."...
..."Names with voiceless fricatives like “f,” for instance, sounded sadder and more insecure than those with voiced fricatives like “v.” ...
...—the unvoiced stops like “p,” “t” and “k”—imply power as we physically force the sound out"...
Hectorsf
..."Branding specialists proclaim that “z,” “k,” “c,” and “g” sound strong and reliable. They assert that plosives like “p,” “t,” “k,” and “c” are powerful-sounding, whereas “l,” “r,” and “s” are calming and relaxing."...
..."Names with voiceless fricatives like “f,” for instance, sounded sadder and more insecure than those with voiced fricatives like “v.” ...
...—the unvoiced stops like “p,” “t” and “k”—imply power as we physically force the sound out"...
Hectorsf
A interesting article on drug name branding.
"A Drug By Any Other Name"
http://scopeweb.mit.edu/?p=262
..."Drug names are restricted by federal guidelines designed to ensure safety and protect copyright. “If it was just the alphabet letters, it would be easy,” says Trombetta. University of Illinois at Chicago linguist Bruce Lambert agrees: “It’s not easy to find a name with all the right connotations, that’s easy to pronounce and remember, and that meets all the constraints simultaneously.” Marketers must find ways to be creative within these sets of restrictions.
When a new drug is developed, it first has a chemical name: for example, 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Next comes its generic name, created by the U.S. Adopted Names Council and often derived from the chemical name to inform medical professionals about the drug’s purpose, mechanism, or content. In this case, it’s diazepam. Then the pharmaceutical company can concoct a few catchy brand names, also called trade names and proprietary names, and submit them to the FDA and the Patent and Trademark Office (PTO). If one gets approved by both agencies—and it’s far from guaranteed; the FDA rejects about a third of the 300-400 drug names it reviews each year—it’s what you’ll see splashed across magazine and Internet ads, prescription pads, and TV commercials. Diazepam becomes Valium.
The FDA’s Center for Drug Evaluation and Research insists that a new drug name be distinctive, so it won’t be confused with preexisting drugs and result in harmful misprescribing. According to the FDA, about ten percent of medication errors by doctors and pharmacists are the result of drug-name confusion. The FDA uses computer software to analyze how close the name is to drugs already on the market, and consults with doctors, nurses and pharmacists to test whether the proposed name looks or sounds like others when it’s written on a prescription pad or spoken over the phone. It’s not always obvious; scrawled in script handwriting, the diabetes drug Avandia has been mistaken for the blood thinner Coumadin. The brand name is also checked against generic names, medical products, and common medical abbreviations (such as “bid” for the Latin bis en die, or “twice a day”). Potentially confusing names are rejected. Sometimes a drug name is approved only to be retracted later. Prilosec began life as Losec but had to be changed when it was repeatedly mixed up with an unrelated drug called Lasix.
Brand names also can’t make medical claims or unsubstantiated promises; imply superiority, effectiveness, or safety; or suggest that the drug can be used for something the FDA hasn’t approved it for. These rules changed the smoking cessation drug Champix, which promised too much by sounding like “champion,” to Chantix. Similarly, Rogaine wasn’t allowed to be called Regaine.
Brand names can get away with slightly more in Europe; Champix and Regaine are acceptable there. But its FDA equivalent, the European Medicines Agency (EMEA), still rejects as many as fifty percent of the drug names it receives. The EMEA’s Name Review Group watches out for name confusion, misleading implicit claims about the drug’s efficacy or purpose, and misinformation about what the drug is made of...."
..."Consonants play a weaker but still influential role. Voiced consonants like “g” and “v” use the vocal cords, while their voiceless equivalents like “k” and “f” don’t. Stops like “p,” “t,” “b,” “g,” “d,” and “k” are so named because air doesn’t come out of the mouth at first, while fricatives like “f,” “s,” “v” and “z” have less flow restriction. Like vowels, voiceless consonants and fricatives have a higher pitch than voiced consonants and stops. Findings like these may be what lies behind marketers’ beliefs that letters like “z” make drugs sound faster and “f” makes them sound softer. This also reveals the foundation beneath drug namers’ claims that plosives—the unvoiced stops like “p,” “t” and “k”—imply power as we physically force the sound out.
Sound symbolism experiments that ask test subjects questions like whether “Pusk” or “Busk” provides faster overnight delivery have found that people apply a range of qualities to the object behind the name based on the consonants it contains. For instance, a 1996 study found that stops sound abrupt, tight, rugged, and inhibited, echoing Piergrossi’s naming rule that ending on an abrupt consonant implies efficacy or a “real end”—both to the word and to the condition it promises to treat. Altogether, sound symbolists have discovered patterns to how people infer things like size, speed, color, sound, gender, personality, and emotions from made-up names. All of these subtle messages work their way into drug names at the hands of savvy advertisers..."
Cheers!
Hectorsf
"A Drug By Any Other Name"
http://scopeweb.mit.edu/?p=262
..."Drug names are restricted by federal guidelines designed to ensure safety and protect copyright. “If it was just the alphabet letters, it would be easy,” says Trombetta. University of Illinois at Chicago linguist Bruce Lambert agrees: “It’s not easy to find a name with all the right connotations, that’s easy to pronounce and remember, and that meets all the constraints simultaneously.” Marketers must find ways to be creative within these sets of restrictions.
When a new drug is developed, it first has a chemical name: for example, 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Next comes its generic name, created by the U.S. Adopted Names Council and often derived from the chemical name to inform medical professionals about the drug’s purpose, mechanism, or content. In this case, it’s diazepam. Then the pharmaceutical company can concoct a few catchy brand names, also called trade names and proprietary names, and submit them to the FDA and the Patent and Trademark Office (PTO). If one gets approved by both agencies—and it’s far from guaranteed; the FDA rejects about a third of the 300-400 drug names it reviews each year—it’s what you’ll see splashed across magazine and Internet ads, prescription pads, and TV commercials. Diazepam becomes Valium.
The FDA’s Center for Drug Evaluation and Research insists that a new drug name be distinctive, so it won’t be confused with preexisting drugs and result in harmful misprescribing. According to the FDA, about ten percent of medication errors by doctors and pharmacists are the result of drug-name confusion. The FDA uses computer software to analyze how close the name is to drugs already on the market, and consults with doctors, nurses and pharmacists to test whether the proposed name looks or sounds like others when it’s written on a prescription pad or spoken over the phone. It’s not always obvious; scrawled in script handwriting, the diabetes drug Avandia has been mistaken for the blood thinner Coumadin. The brand name is also checked against generic names, medical products, and common medical abbreviations (such as “bid” for the Latin bis en die, or “twice a day”). Potentially confusing names are rejected. Sometimes a drug name is approved only to be retracted later. Prilosec began life as Losec but had to be changed when it was repeatedly mixed up with an unrelated drug called Lasix.
Brand names also can’t make medical claims or unsubstantiated promises; imply superiority, effectiveness, or safety; or suggest that the drug can be used for something the FDA hasn’t approved it for. These rules changed the smoking cessation drug Champix, which promised too much by sounding like “champion,” to Chantix. Similarly, Rogaine wasn’t allowed to be called Regaine.
Brand names can get away with slightly more in Europe; Champix and Regaine are acceptable there. But its FDA equivalent, the European Medicines Agency (EMEA), still rejects as many as fifty percent of the drug names it receives. The EMEA’s Name Review Group watches out for name confusion, misleading implicit claims about the drug’s efficacy or purpose, and misinformation about what the drug is made of...."
..."Consonants play a weaker but still influential role. Voiced consonants like “g” and “v” use the vocal cords, while their voiceless equivalents like “k” and “f” don’t. Stops like “p,” “t,” “b,” “g,” “d,” and “k” are so named because air doesn’t come out of the mouth at first, while fricatives like “f,” “s,” “v” and “z” have less flow restriction. Like vowels, voiceless consonants and fricatives have a higher pitch than voiced consonants and stops. Findings like these may be what lies behind marketers’ beliefs that letters like “z” make drugs sound faster and “f” makes them sound softer. This also reveals the foundation beneath drug namers’ claims that plosives—the unvoiced stops like “p,” “t” and “k”—imply power as we physically force the sound out.
Sound symbolism experiments that ask test subjects questions like whether “Pusk” or “Busk” provides faster overnight delivery have found that people apply a range of qualities to the object behind the name based on the consonants it contains. For instance, a 1996 study found that stops sound abrupt, tight, rugged, and inhibited, echoing Piergrossi’s naming rule that ending on an abrupt consonant implies efficacy or a “real end”—both to the word and to the condition it promises to treat. Altogether, sound symbolists have discovered patterns to how people infer things like size, speed, color, sound, gender, personality, and emotions from made-up names. All of these subtle messages work their way into drug names at the hands of savvy advertisers..."
Cheers!
Hectorsf
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