Trial Outcomes & Findings for An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects (NCT NCT01666119)

NCT ID: NCT01666119

Last Updated: 2017-04-04

Results Overview

Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in \> 2 subjects, the total number of unique events that were experienced are reported.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 249 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-04-04

Participant Flow

Participant milestones

Measure	BEMA Buprenorphine NX Films BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg). BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg).
Overall Study STARTED	249
Overall Study COMPLETED	197
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Measure	BEMA Buprenorphine NX Films BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg). BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg).
Overall Study Adverse Event	6
Overall Study Withdrawal by Subject	16
Overall Study Lost to Follow-up	7
Overall Study non compliance with study medication, pa	18
Overall Study Subject experiencing withdrawal symptoms	5

Baseline Characteristics

An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects

Baseline characteristics by cohort

Measure	BEMA Buprenorphine NX Films n=249 Participants BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively. BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.
Age, Continuous	38.7 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants
Sex: Female, Male Male	164 Participants n=5 Participants
Region of Enrollment United States	249 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: All subjects who received at least 1 dose of study drug.

Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in > 2 subjects, the total number of unique events that were experienced are reported.

Outcome measures

Measure	BEMA Buprenorphine/NX Films n=249 Participants BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)
Adverse Events	36 adverse events

SECONDARY outcome

Timeframe: 12 weeks

Population: Subjects with at least one urine drug screen test during the treatment period.

Urine samples collected at screening and baseline to test for the presence of non-prescribed opioids.

Outcome measures

Measure	BEMA Buprenorphine/NX Films n=249 Participants BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)
Urine Drug Screen Subjects with +-result for non-prescribed opiod	19 participants
Urine Drug Screen Number with single positive result	11 participants
Urine Drug Screen Number with 2 positive results	4 participants
Urine Drug Screen Number with > 2 positive results	4 participants

Adverse Events

BEMA Buprenorphine NX Films

Serious events: 1 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Measure	BEMA Buprenorphine NX Films n=249 participants at risk BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively. BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.
Infections and infestations osteomyelitis	0.40% 1/249 • Number of events 1
Psychiatric disorders suicidal ideation	0.40% 1/249 • Number of events 1

Other adverse events

Measure	BEMA Buprenorphine NX Films n=249 participants at risk BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively. BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.
General disorders drug withdrawal syndrome	35.7% 89/249 • Number of events 89

Additional Information

Enoch Bortey

BDSI

Phone: 919 582 9050

Email: ebortey@bdsi.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place