(BDSI) has received approval from a California panel to resume patient recruitment and add new sites for a drug trial in that state.
The Research Advisory Panel of California approved BDSI's request to enroll patients and to add sites for the Phase III trial of its BEMA Fentanyl product. The drug, to be delivered through an oral patch, is for treatment of intense, or breakthrough, pain.
The panel had ordered BDSI to stop the trial until it could review BDSI's informed-consent documentation.
BDSI hopes to file a new drug application for BEMA Fentanyl in the second quarter of next year.
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