Endo, BDSI buoyed as PhIII pain drug success clears path to FDA

July 7, 2014 1:32 PM

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More than two years ago the pain specialist Endo Pharmaceuticals ($ENDP) stepped up with a $180 million deal to license rights to BEMA Buprenorphine, a pain therapy that had been repackaged using delivery tech from BioDelivery Sciences International ($BDSI), even though it had just failed the primary endpoint in a critical Phase III study. Today, Endo put out the word that its gamble had paid off, saying that a new Phase III trial hit the goal line on reduction in pain compared to a placebo, putting the treatment on a path to the FDA for a marketing decision.

BEMA--or BioErodable MucoAdhesive--technology relies on a dissolvable polymer from BDSI that is put on the inside of the cheek, delivering its dose through the mucous membranes in less than 30 minutes so patients can get a quick hit of pain relief from the buprenorphine in the package.

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