This approval allows BDSI to continue recruitment at existing investigational sites and initiate new sites in California. The panel had mandated a temporary pause in recruitment pending a review of the trial, as required under California law.
Bema Fentanyl is being targeted for the treatment of “breakthrough” cancer pain.
The approval enables the company to continue patient enrollment for Bema Fentanyl. BDSI also said study results would be included in the company’s upcoming NDA submission on the treatment
BDSI recently announced that the company intends to submit its NDA on Bema Fentanyl to the FDA during the second quarter of 2007.
The company also recently announced a licensing arrangement with Meda AB of Sweden for the distribution of BEMA Fentanyl in Europe following regulatory approval there.