Well, apparently sugammadex will eventually be called Bridion, that is, of course, if we ever get it. Read on. The link from pharmalot.com is here as well as the full text. There is also an FDA website link. I will try to add this into a later response.
http://www.pharmalot.com/2008/03/more-studies-for-schering-plough-anesthesia-drug/#more-12371
More Studies For Schering-Plough Anesthesia Drug?
March 7th, 2008 1:41 pm By Ed Silverman
This is going to be crucial for the drugmaker, which is reeling from the downturn in Vytorin scripts. FDA medical reviewers believe the drug, which is known as Sugammadex and would reverse the effects of anesthesia, appears to be safe, but they question how Schering-Plough defined effectiveness in a key study, the Associated Press reports.
The agency is also still waiting for data on a rare occurrence of hypersensitivity reactions in some patients from to the drug, the reviewers wrote in briefing documents posted on the FDA site. (You can read those right here). The review comes ahead of an advisory panel meeting next week.
The drug seeks to reverse the muscular blocking effects of certain muscle relaxants, to help patients recover more quickly from anesthesia after medical procedures. And some Wall Street analysts believe Sugammadex could generate up to $1 billion in annual revenue.
Similar drugs are on the market, but Schering-Plough contends the drug is unique because it reverses the effects of mild and serious anesthesia. FDA reviewers wrote that the med appears safe in healthy adults, but that additional studies may be needed to answer questions about allergic reactions and the drug’s effects on children’s’ teeth.
The agency is concerned about reports of some adults having hypersensitivity reactions while taking the drug. Schering-Plough is studying the reactions, and FDA said the results “could have a significant effect on the overall finding of safety” for the drug. The agency also says the drugmaker hasn’t addressed effects on teeth in young children. Studies of the drug in young rats showed it interfered with growth of tooth enamel.
Studies of the drug in human adults also showed minor changes in bone strength, though they were not considered significant. Only one study of Bridion in children has been completed, the FDA wrote. The agency will ask its advisers Tuesday whether the company should be required to conduct additional studies in children.
In a question for the panel to consider, FDA staff ask whether the study goal aimed at proving efficacy has “clinical relevance,” especially in emergency room situations.
“In summary, the Applicant appears to have made a thorough assessment of the safety of Bridion in a relatively healthy adult population and with the possible exception of hypersensitivity, found the drug product to be safe compared” with current agents, the FDA staff said.
The most common side effects associated with the drug are pain and nausea, with rare cases of severe anaphylactic reactions, a dangerous allergic reaction that can be life- threatening, according to the company.
http://www.pharmalot.com/2008/03/more-studies-for-schering-plough-anesthesia-drug/#more-12371
More Studies For Schering-Plough Anesthesia Drug?
March 7th, 2008 1:41 pm By Ed Silverman
This is going to be crucial for the drugmaker, which is reeling from the downturn in Vytorin scripts. FDA medical reviewers believe the drug, which is known as Sugammadex and would reverse the effects of anesthesia, appears to be safe, but they question how Schering-Plough defined effectiveness in a key study, the Associated Press reports.
The agency is also still waiting for data on a rare occurrence of hypersensitivity reactions in some patients from to the drug, the reviewers wrote in briefing documents posted on the FDA site. (You can read those right here). The review comes ahead of an advisory panel meeting next week.
The drug seeks to reverse the muscular blocking effects of certain muscle relaxants, to help patients recover more quickly from anesthesia after medical procedures. And some Wall Street analysts believe Sugammadex could generate up to $1 billion in annual revenue.
Similar drugs are on the market, but Schering-Plough contends the drug is unique because it reverses the effects of mild and serious anesthesia. FDA reviewers wrote that the med appears safe in healthy adults, but that additional studies may be needed to answer questions about allergic reactions and the drug’s effects on children’s’ teeth.
The agency is concerned about reports of some adults having hypersensitivity reactions while taking the drug. Schering-Plough is studying the reactions, and FDA said the results “could have a significant effect on the overall finding of safety” for the drug. The agency also says the drugmaker hasn’t addressed effects on teeth in young children. Studies of the drug in young rats showed it interfered with growth of tooth enamel.
Studies of the drug in human adults also showed minor changes in bone strength, though they were not considered significant. Only one study of Bridion in children has been completed, the FDA wrote. The agency will ask its advisers Tuesday whether the company should be required to conduct additional studies in children.
In a question for the panel to consider, FDA staff ask whether the study goal aimed at proving efficacy has “clinical relevance,” especially in emergency room situations.
“In summary, the Applicant appears to have made a thorough assessment of the safety of Bridion in a relatively healthy adult population and with the possible exception of hypersensitivity, found the drug product to be safe compared” with current agents, the FDA staff said.
The most common side effects associated with the drug are pain and nausea, with rare cases of severe anaphylactic reactions, a dangerous allergic reaction that can be life- threatening, according to the company.