- Endo Pharmaceuticals (NASDAQ:ENDP) and BioDelivery Sciences (NASDAQ:BDSI) announce that the Phase 3 clinical trial of BEMA buprenorphine as a treatment for severe pain achieved its primary efficacy endpoint of a statistically significant improvement in chronic pain relief versus placebo in patients with pain severe enough to require daily, 24-hour, long-term opioid treatment for which alternative treatment options are inadequate.
- Under the terms of their licensing agreement, the locking of the database for the opioid-experienced study triggers a $10M milestone payment from ENDP to BDSI.
- Endo has a pre-NDA meeting scheduled with the FDA this month and intends to complete its regulatory submission as soon as possible.
- BDSI shares are up 15% premarket on robust volume.