Perinatal EvidenceCompass
Prepopulated workbenchMED-217

Substance-use disorder — opioid

Buprenorphine extended-release weekly/monthly injection

Medication for opioid use disorder, withdrawal, or overdose rescue

Brand / product examples: Brixadi

Not a categorical safety rating

This record organizes questions; it does not close them.

The clinical fields and position statements are prepopulated from the public-source corpus. They have not completed individual dual extraction, formal appraisal, exact-label reconciliation, or multidisciplinary sign-off. Do not use this page to justify abrupt discontinuation or reflexive switching.

Inventory identity

What this record represents

Canonical generic name
Buprenorphine extended-release weekly/monthly injection
Entity type
single-ingredient drug
Active component(s)
Buprenorphine
Formulation / route / interval
Subcutaneous depot injection; weekly or monthly
Attachment entry
Extended-release buprenorphine injections
Separate monograph status
Yes — interval-specific depot product
Identity and cross-reference
Not populated in v0.95
Inventory verification confidence
Moderate — molecule-level source; exact product/jurisdiction pending

Decision taxonomy

Five positions kept separate

These are workbench statements for reviewer execution. They are not independently commissioned, patient-specific recommendations.

  1. 01

    Stable continuation

    Workbench statement

    Do not withhold or discontinue solely because of pregnancy or lactation. For this record, assess indication, prior response, relapse severity, dose/formulation, alternatives, exposure timing, and mapped evidence; individual commissioned adjudication remains pending.

  2. 02

    New initiation in pregnancy

    Workbench statement

    For a new start, prefer an effective option with the strongest diagnosis-specific efficacy and reproductive evidence when clinically suitable. This record has not received an individual, independently verified initiation ranking.

  3. 03

    Switch before conception

    Workbench statement

    Before conception, consider a switch only when expected benefit exceeds relapse, withdrawal, failed-switch, and dual-exposure risks. Build and monitor the plan before pregnancy when feasible; no universal switch direction is assigned here.

  4. 04

    Unplanned exposure

    Workbench statement

    After unplanned exposure, confirm product, route, dose, timing, indication, co-exposures, and symptoms; do not advise abrupt cessation. Use the mapped evidence and current label to decide whether any targeted fetal assessment is indicated.

  5. 05

    Delivery, postpartum & lactation

    Workbench statement

    Create separate delivery, postpartum-dose, neonatal-observation, and lactation plans. Do not infer breastfeeding suitability from pregnancy evidence or routinely taper before delivery without drug-specific support.

Linked evidence

3 mapped claim summaries

Mapping can include class-wide, framework, formulation, regulatory, or evidence-gap claims. A linked claim is not necessarily a drug-specific causal estimate.

C-005Provisional public source

In a 2026 open-label randomized trial, weekly extended-release buprenorphine/CAM2038 produced more illicit-opioid-negative weekly urine samples during pregnancy than sublingual buprenorphine.

Public-source certainty descriptor
Moderate; randomized but open-label and modest-sized
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
6 to 30 weeks gestation through delivery
Comparator
Weekly Brixadi/CAM2038 versus sublingual buprenorphine
Effect or numbers carried forward

82.5% versus 72.6%; mean difference 9.84 percentage points, 95% CI 1.72 to 17.95

Limitations

140 participants at 13 US sites; almost all were already taking sublingual buprenorphine; limited diversity and site variation; the current corrected article was used

Sources, citation controls, and verification state

Linked sources

PMID
Not populated in v0.95
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending
C-006Provisional public source

The 2026 weekly CAM2038 result must not be extrapolated to monthly Brixadi, Sublocade, Buvidal labeling, Probuphine, or Sixmo; these formulations differ in delivery, residual release, removability, jurisdiction, and evidence.

Public-source certainty descriptor
High boundary certainty; very low direct evidence for several formulations
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
Pregnancy and postpartum
Comparator
Other depot or implant formulations versus weekly CAM2038
Effect or numbers carried forward

Direct randomized pregnancy evidence applies to weekly CAM2038 only

Limitations

Absence of direct evidence does not prove harm; forced switching can destabilize OUD

Sources, citation controls, and verification state

Linked sources

PMID
41837971
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending
C-007Provisional public source

In the 2026 trial, estimates for infant opioid treatment for NOWS and treatment duration were imprecise and compatible with benefit or harm; the trial did not establish neonatal equivalence.

Public-source certainty descriptor
Moderate-low; secondary outcomes and variable site scoring
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
Late pregnancy and neonatal period
Comparator
Weekly CAM2038 versus sublingual buprenorphine
Effect or numbers carried forward

Infant opioid treatment: 30.2% versus 26.5%, RR 1.14 (98% CI 0.54–1.99), P=.64; mean treatment days: 10.9 (SE 2.2) versus 14.8 (SE 3.0), ratio 0.73 (98% CI 0.36–1.51), P=.28.

Limitations

Trial not powered to prove neonatal equivalence; NOWS assessment varied by site

Sources, citation controls, and verification state

Linked sources

PMID
41837971
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending