FDA ad­vi­so­ry group re­jects Paci­ra’s pitch for ex­pand­ed use of pain drug

A group of ex­perts or­ga­nized by the FDA has vot­ed 6 to 4 against a move by Paci­ra Phar­ma­ceu­ti­cals to get an ap­proval to use its pain drug Ex­par­el as a re­gion­al pain block­er, ex­pand­ing on its ap­proved use as a lo­cal anes­thet­ic. And now the biotech may have to mount some new stud­ies if it plans to pur­sue this much fur­ther.

In a nov­el use of lan­guage, the com­pa­ny not­ed in a state­ment that the ad­vi­so­ry group “did not reach a unan­i­mous de­ci­sion on the ef­fi­ca­cy and safe­ty of the use of Ex­par­el.”

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