An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
This is an open label study in opioid dependent subjects maintained on a stabilized dose of
Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA
Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized
on Suboxone (buprenorphine/naloxone) tablets or films.
Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX.
This dose will be taken throughout the 12-week treatment period with dose adjustments as
clinically indicated for either the control of opioid dependence or adverse events (AEs).
Phase:
Phase 2
Details
Lead Sponsor:
BioDelivery Sciences International
Treatments:
Analgesics, Opioid Buprenorphine Buprenorphine, Naloxone Drug Combination