Last reviewed 2026-04-20 · How we verify

Orlaam (LEVOMETHADYL ACETATE)

Levomethadyl Acetate (Orlaam), marketed by Roxane, is a medication indicated for the treatment of opioid dependence, competing in a class with buprenorphine, methadone, and lofexidine. Orlaam's unique mechanism of action, targeting the potassium voltage-gated channel subfamily H member 2, distinguishes it from other opioids and may offer a novel approach to managing withdrawal symptoms and cravings. The primary risk to Orlaam's market position is the strong presence of off-patent generics, particularly methadone, which has 13 generic formulations, and the upcoming key composition patent expiry in 2028.

At a glance

Approved indications

• Opioid dependence

Common side effects

No common side effects on file.

Drug interactions

• High Risk QT Prolonging Agents
• itraconazole
• naltrexone
• pentazocine
• phenobarbital
• phenytoin
• tramadol
• zidovudine

Key clinical trials

• Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers (NA)
• LAAM-HAART PET Imaging (EARLY_PHASE1)
• Feasibility Study of Take-Home LAAM Medication - 3 (PHASE4)
• Evaluation of L-alpha-acetylmethadol (LAAM) in Methadone Patients - 5 (PHASE2)
• Treatment of Opioid/Heroin Dependence: Comparison of Three Medication Dosing Regimens (PHASE2)
• The Efficacy of Methadyl Acetate (LAAM) and Contingency Management Procedures for Treating Dual Opioid and Cocaine Abuse - 1 (PHASE2)
• Opioid Maintenance Medications Comparison Study (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Orlaam CI brief — competitive landscape report
• Orlaam updates RSS · CI watch RSS
• Roxane portfolio CI