Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence

This was a multicenter, open-label, uncontrolled, single-arm, 24-week, extension study to
assess safety, efficacy, and treatment retention during maintenance treatment.

Eligible patients had completed 1 of 2 primary efficacy and safety studies of the
higher-bioavailability BNX sublingual tablet formulation (primary study OX219-006
[NCT01908842] or OX219-007 [NCT01848054]). The total duration of study treatment was 24
weeks.

Inclusion criteria

- Signed informed consent form.

- Completion of 1 of 2 primary efficacy safety studies of BNX sublingual tablets
(OX219-006 or OX219-007).

- Female patients of child bearing potential who used a reliable method of
contraception (hormonal, condom with spermicide, intrauterine device) during the
previous OX219-006 or OX219-007 study and continue to use it for the OX219-008 study.
Females who are not of child-bearing potential who are either surgically sterile (by
hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation), or
postmenopausal, as defined by being at least 50 years of age and having had an
absence of menses for at least 2 years, were also eligible.

Exclusion criteria

- Females who are pregnant (positive pregnancy test result) or lactating, or planning
to become pregnant during the study.

- Participants who are unwilling or unable to comply with the requirements of the
protocol (eg, pending incarceration) or are in a situation or condition that, in the
opinion of the investigator, may interfere with participation in the study.

- Participants who are participating in any other clinical study in which medication(s)
are being delivered or who had used an investigational drug or device within the last
30 days.

- Participants with any known allergy or sensitivity or intolerance to buprenorphine,
naloxone, or any related drug, or history of any drug hypersensitivity or intolerance
that, in the opinion of the investigator, would compromise the safety of the subject
or the study.

- Participant with a contra-indicated serious medical condition.

- Participants who are at suicidal risk as determined by any of the following: a
history of suicidal ideation ≤ 3 months prior to baseline with a score of 4 (intent
to act) or 5 (specified plan and intent) on the Columbia Suicide Severity Risk Scale
(C-SSRS).