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Merck resubmits anaesthesia drug Bridion in US

FDA previous the neuromuscular reversal agent in 2008

Merck and Co - US headquartersMerck & Co says the US FDA has accepted its new filing for neuromuscular reversal agent Bridion after turning down its first marketing application for the drug in 2008.

Bridion (sugammadex) reverses the effects of strong muscle relaxants given during surgery such as rocuronium or vecuronium. The drug appears to help patients come out of anaesthesia more quickly and with fewer side effects than competing agents. 

The clinical profile of the drug means that it can allow anaesthesiologists to rapidly and safely reverse both shallow and profound levels of muscle relaxation, which is not possible with current reversal agents.

If approved, sugammadex will be the first in a new class of drugs in the US known as selective relaxant binding agents which encapsulate the muscle relaxant molecule and render it inactive. 

The product is already approved in Europe and some other countries, bringing in sales of $186m in the first nine months of 2012, and Merck chief executive Kenneth Frazier said last year that with US approval it could be an "important product" for the company.

There are around 30m surgeries carried out per year in the US, and muscle relaxants are used in around half of that total. Merck believes that in the majority of cases the effects of the muscle relaxants are reversed, so an agent that can improve hospital efficiency by hastening patient recovery could be "very helpful", according to Frazier.

The growth trajectory for the product outside the US seems to be pretty good, with 2009 sales of $40m rising to $100m in 2010 and looking set to more than double once again for 2012 as a whole.

Analysts have suggested in the past that Bridion could achieve sales of $400m-$700m a year with US approval, depending on pricing and how successful Merck is in positioning it against established generic reversal agents such as suxamethonium, neostigmine and pyridostigmine.

The FDA turned down Merck's original filing for sugammadex on concerns related to allergic reactions and bleeding events, and the company says it has filed new data on these side effects.

9th January 2013

From: Sales



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