Schering-Plough’s Bridion Makes Positive Impression On Advisory Panel

Advisory committee agrees sugammadex data on routine reversal of neuromuscular blockade is clinically relevant.

Although the Anesthetic and Life Support Drugs Advisory Committee's review of Schering-Plough's Bridion (sugammadex) was somewhat complicated by the eleventh hour submission of additional data, panel members overwhelmingly backed the selective relaxant binding agent on all fronts.

Sugammadex, under review for the routine reversal of shallow and profound neuromuscular blockade, as well as "immediate" NMB reversal, got the committee's nod for both indications. The panel also supported its use in pediatric settings.

The committee made no official recommendation to FDA, as the agency has not yet completed its review of the drug's efficacy and safety data; the agency presented its initial findings at the March 11 meeting.

FDA is continuing to review data recently submitted by Kenilworth, N.J.-based Schering-Plough on hypersensitivity and Bridion's use in the pediatric setting, and the advisory group discussed the preliminary results on those issues.

Specifically, the committee voted unanimously that the primary endpoint - the time from start of administration of rocuronium or succinylcholine to the recovery of T1 to 10 percent of its baseline value - is clinically relevant.

The committee also voted, although with more hesitation, that based on the data submitted there is sufficient clinical evidence that sugammadex, when used with rocuronium, provides a clear advantage when confronted with Cannot Ventilate, Cannot Intubate scenarios (¹ (Also see "Anesthesia Advisory Committee To Review Schering-Plough’s Bridion For Novel Indication" - Pink Sheet, 7 Mar, 2008.)).

Sugammadex was not tested in the CVCI or emergency scenario, however, and FDA representatives said in their presentation that the sponsor's extrapolation of the results from one study to an emergency or CVCI situation is not supported.

While committee members agreed that there was no direct evidence to support use of Bridion in that setting, they contended there was also no reason why it should not work. Also, they pointed out that it would be unethical to run a trial to test Bridion in emergency situations.

Schering-Plough submitted data on hypersensitivity directly before the advisory committee, and FDA added a question on whether that data adequately demonstrates that sugammadex can be used safely in the targeted population with specific potential for hypersensitivity.

Committee members across the board agreed that the sponsor's hypersensitivity data demonstrated that the drug can be used safely. They did, however, recommend postmarketing surveillance.

The panel additionally requested more information on pediatric use involving multiple doses.

Schering-Plough reported that it is "very pleased with the outcome of today's advisory committee." The selective relaxant binding agent is receiving a priority review, and FDA action is expected in the second quarter.

-Lauren Smith ([email protected])