After rejecting Merck’s muscle relaxant Bridion (sugammadex) three times in a row, the US Food and Drug Administration has finally approved the drug. Since the past, seven years that pharmaceutical company has been trying to make the American agency understand the abilities of the drug and has succeeded in doing so in its fourth attempt.
The company representatives said that they were always convinced about Bridion’s huge market potential, which allowed them to remain upbeat in spite of three consecutive rejections.
Dr. Sharon Hertz, the director of the Division of Anesthesia, Analgesia & Addiction Products at FDA’s Center for Drug Evaluation & Research, said that approval of Bridion provides medical practitioners with a new treatment option which might help patients recover from effects of medications used for ventilation or intubation during surgery at a much greater pace.
Dr. Hertz added that the drug would be allowing medical personnel in reversing effects of neuromuscular blockers and restoring the patient’s spontaneous breathing post surgery.
Since the time Schering-Plough started making the drug, health officials have been questioning the drug’s chances of causing negative side effects. The regulators talked about possibilities that on rare occasions the patients treated with the drug might experience anaphylaxis. For those who don’t know: anaphylaxis is a severe and potentially fatal allergic reaction.
The health officials also warned doctors to monitor the drug’s role in slowing down heart action which might eventually lead to cardiac arrest. These safety concerns and some more resulted in demands for constant regulatory delays and new studies for clearing doubts surrounding the drug.
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This long and unrelenting uncertainty over sugammadex resulted in the formation of a crisis situation at Merck two years back. The crisis also caused a switch at the company’s R&D department. The department got a new leader in Roger Perlmutter, who came in with major cost cutting and revamping plans. Perlmutter’s plans worked, and the company finally succeeded in earning FDA’s approval for its muscle relaxant Bridion.
There are several countries around the globe where the use of Bridion was already legal. Some analysts feel that the medication’s approval in the United States might allow the company to complete sales worth over $700 million. However, there are also some who are not expecting the drug to bring in so much revenue.
