More Studies For Schering-Plough Anesthesia Drug?
3 CommentsBy Ed Silverman // March 7th, 2008 // 1:41 pm
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 to the drug, the reviewers wrote in briefing documents posted on the FDA site. (You can read those 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 and help patients recover more quickly from anesthesia after procedures. 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.
Der Waarheid
As an Organon rep who has sold both vec and roc over the past 15 years, let me clarify a few points.
There is NOTHING like sugammadex on the market at this time. With the first signs of recovery from NMB, you can give neostigmine or pyridostigmine to adjust the balance of acetylcholine to vec/roc (or any other SMR for that matter, but sugammadex will only neutralize roc or vec)in the neuromuscular junction. For roc, recovery decreases from 13 to 5 minutes. You also have to use glyccopyrolate or atropine to counter the CV effects. With sugammadex, roc or vec can be reversed at any time within 3-5 minutes. It is a true anti-dote as it binds to roc or vec creating an umbreakable bond.
Now the problem. Anesthesiologists tend to run their cases very efficiently and though not perfeect, the neo/glyc (or pyr/atr) reversal is efficient, cheap and presents very few problems. Most are very happy with these cocktails. Reversal and recurisation don’t seem to present a pressing patient crisis. Alternatively, SP is projecting to make sugammadex absurdly expensive despite the fact that Organon was able to develop this drug on a shoestring, probably spending relatively little (by todays testing standards) on a fairly simple, straightforward clinical trial and apparently has a projected patent expiration date of 2024!!!
It is only my humble opinion, but this drug won’t make $1 billion in ten years. Most hospital pharmacies are not going to leave a $50+/dose drug on the shelf for general use when their is a $1 alternative. Most anesthesiologists will also balk at this cost unless their is an absolute benefit to the patient. A failed intubation with roc will pass this test, general extubations will not. If at present we are only making about $200 million/yr on Zemuron (roc), how are we going to generate $1 billion dollars on sug.
Johann Wang
I agree with Der Waarheid. As an anesthesiologist, I rarely use muscle relaxant unless necessary. Even when I do use muscle relaxant, I hardly use a full dose (in which I won’t be able to adequately reverse if necessary.) This drug would prabably most useful in teaching settings where residents or nurse anesthesist students tend to give too much relaxant. In private practice, I can’t see how you can justify using a drug that is several times more expensive than neostigmine which cost less than $1.00. If SP is going to try to milk the medical community, I think it’s going to backfire. It is sad since the concept of sugamma*** is so awesome. Oh well.
Cristian
The FDA have a tough problem on their hands: not failing to fight the drug industry because certain drug company owners want unsafe drugs on the market just to make a profit.