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Experimental anti-anesthesia drug beats standard treatment, study says

An experimental drug worked many times faster than a standard treatment in helping surgery patients recover from anesthesia, according to a just-published study funded by its developer, Schering-Plough Corp.

The drug, known chemically as sugammadex, reverses the effects of muscle-relaxing drugs given along with anesthetics to prevent patients from moving, making operations safer for them and easier for the surgeon.

This would be the first new treatment for reversing muscle relaxers since the 1960s and would significantly improve patient safety, John Dombrowski, a member of the Board of Directors at the American Society of Anesthesiologists, said on Tuesday.

The two long-standard drugs can take more than an hour to work — a period when the patient is vulnerable to life-threatening breathing complications — compared with three minutes or less for sugammadex.

Already, it is being launched under the brand name Bridion in Europe, where it was approved in July. But US regulators unexpectedly rejected it in August, citing concerns about allergic reactions in a couple patients, even though an advisory panel had unanimously recommended it.

“This is a tragedy that this didn’t get approved,” said Dombrowski, an anesthesiologist at the Washington Pain Center in Washington who does not have industry ties.

Kenilworth, New Jersey-based Schering-Plough is planning to meet with officials at the Food and Drug Administration “to get a better understanding of their issues” and work through them to win approval, company spokesman Robert Cansalvo said.

“We’re committed to bringing the drug to the US market,” Cansalvo said.

In the 88-patient study, published in next month’s issue of the journal Anesthesiology and now available online, about half of the participants were injected with sugammadex at the end of surgery and the rest were injected with a standard treatments called neostigmine.

Patients getting sugammadex recovered from the muscle relaxers about 17 times faster, on average, than those getting neostigmine.

The median recovery time — the point where half fall above and half fall below — was 2.7 minutes for the sugammadex patients versus 49 minutes for the neostigmine patients.

A nerve stimulator attached to one hand was used to monitor how quickly the patient recovered the use of muscles and could breathe well enough to be removed from a ventilator, as is routinely done in surgery.
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