BioDelivery Sciences (BDSI) reported positive top-line results on Monday from the second of two pivotal trials of BEMA-buprenorphine, this study in opioid-experienced patients with chronic lower back pain. Another phase 3 trial of BEMA-Buprenorphine, a patch that adheres to the inner cheek, in opioid-inexperienced subjects was completed with positive results in January of 2014, significant because these same patients (opioid-inexperienced) confounded a previous late-stage study in 2011.
PropThink wrote about the previous failure in detail to Premium members this February, explaining why we expected positive results from the opioid-experienced trial this summer. More importantly, since Mr. Deryugin suggested in December that BioDelivery Sciences would be delivering profits in 2014, this pick is up 175%.
With successful -experienced and-inexperienced trials, BDSI and partner Endo International (ENDP) will submit a New Drug Application to the FDA this year; a pre-NDA meeting is scheduled for July. BioDelivery Sciences also announced on June 26 enrollment completion for its phase 3 study of Clonidine Topical Gel in painful diabetic neuropathy. The RHAPSODY Study is a 140-patient, 12-week double-blind comparison of Clonidine Topical Gel to placebo. It is the first of two pivotal trials by the FDA. BDSI expects top-line data by the end of the year.
Database lock for the phase 3 opioid-experienced trial resulted in a $10 million milestone payment from Endo to BDSI.
One or more of PropThink’s contributors are long BDSI.
