BioDelivery Sciences International (BDSI +1.2%) reports that supplies of Bunavail (buprenorphine and naloxone) buccal film (CIII) have been shipped to U.S. wholesalers and the U.S. launch of the opioid dependence treatment is now underway.
Endo Pharmaceuticals (ENDP) and BioDelivery Sciences (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.
BioDelivery Sciences (BDSI) completes enrollment of its 140-patient 12-week double-blind Phase 3 clinical trial to evaluate Clonidine Topical Gel as a treatment for painful diabetic neuropathy (PDN). This is the first of two Phase 3 studies that will be required for an NDA submission for the Fast Track-designated product. The second trial will commence in Q1 2015.
The company expects to complete an interim analysis of the data based on 50% of the patients in Q3 2014.
The study subjects demonstrate functional skin nociceptors. This group showed statistically significant efficacy compared to placebo in a previous Phase 2 trial.
Shares of BioDelivery Sciences International (BDSI +14.3%) break out of a cup-with-a-handle base on a 4x surge in volume. Investors apparently like the company's prospects after the FDA approval of Bunavail.
Shares of BioDelivery Sciences (BDSI) are set to jump past resistance at $10 at the open this morning. Shares are up 4% premarket to $10.40 on modest volume. Friday after the close the company announced the FDA approval of Bunavail, a treatment for opioid dependence.
The review of BioDelivery Sciences' (BDSI) Bunavail New Drug Application is expected to be completed by June 2014, says the company, which believes the drug has the potential to generate peak U.S. sales of up to $250M.
BioDelivery Sciences International Inc along with its subsidiaries is a specialty pharmaceutical company that is developing and commercializing new applications of proven therapeutics to address important unmet medical needs.