FDA-Approved MedicationUpdated November 2026

Contrave Guide

Contrave is a fixed-dose oral combination of naltrexone HCl 8 mg (an opioid receptor antagonist) and bupropion HCl 90 mg (a dopamine and norepinephrine reuptake inhibitor) formulated as an extended-release tablet for chronic weight management. It was FDA-approved September 10, 2014. Azurity Pharmaceuticals acquired Contrave in June 2026 and is now the application holder at FDA. The current DailyMed label still names Nalpropion Pharmaceuticals LLC as labeler and Currax Pharmaceuticals as distributor. No GLP-1 receptor is involved. Contrave works in the brain instead, on appetite-regulating hypothalamic neurons and on the mesolimbic dopamine reward circuit. Average weight loss in the pivotal COR trials at the 32 mg / 360 mg daily maintenance dose was roughly 4-5% body weight at 56 weeks placebo-subtracted, substantially less than GLP-1s like Wegovy (~14.9%) or Zepbound (~20.9%), positioning Contrave as a lower-cost option for patients who cannot tolerate GLP-1 gastrointestinal side effects or who have co-occurring nicotine or alcohol use disorder where bupropion or naltrexone may offer secondary benefit.

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By Ruth Calder · Enforcement Editor
Editorially reviewed. Not medical advice · How we verify contentLast reviewed

At a Glance

Contrave at a glance
Generic NameNaltrexone hydrochloride / Bupropion hydrochloride
Brand NamesContrave
FDA StatusFDA-approved for chronic weight management in adults with obesity, or overweight with at least one weight-related comorbidity (September 10, 2014). Originally developed by Orexigen Therapeutics; Orexigen filed Chapter 11 in 2018 and the Contrave assets were acquired by Nalpropion Pharmaceuticals (a joint venture of Pernix Therapeutics and a Highbridge-led investor group). Nalpropion was subsequently rolled up into Currax Pharmaceuticals. Azurity Pharmaceuticals announced it had acquired Contrave in June 2026; Drugs@FDA now lists Azurity as sponsor of NDA 200063. Not FDA-approved for pediatric use.[1]
Approval DateSeptember 10, 2014[1]

How does Contrave work?

Bupropion stimulates hypothalamic pro-opiomelanocortin (POMC) neurons, which release alpha-MSH to reduce appetite, but POMC neurons also release beta-endorphin, which feeds back onto mu-opioid receptors on the POMC neurons themselves and shuts them off — limiting the appetite-suppressing effect. Naltrexone, by blocking those mu-opioid receptors, disables that auto-inhibitory feedback loop and allows bupropion's POMC activation to persist longer and more strongly. The two agents together also modulate the mesolimbic dopamine reward circuit (ventral tegmental area to nucleus accumbens), which is thought to reduce food cravings and the hedonic drive to eat palatable foods.[2]

Dosing Schedule

Contrave uses a gradual dose escalation to minimize side effects. Always follow your prescriber's guidance and the current FDA label[1].

Week 11 tablet (8 mg naltrexone / 90 mg bupropion) in the morning; no evening dose
Week 21 tablet in the morning and 1 tablet in the evening (16 mg / 180 mg total daily)
Week 32 tablets in the morning and 1 tablet in the evening (24 mg / 270 mg total daily)
Week 4 onward2 tablets in the morning and 2 tablets in the evening — maintenance dose 32 mg naltrexone / 360 mg bupropion total daily

What side effects does Contrave cause?

Common (≥5% and ≥1.5× placebo in pooled phase 3 trials): nausea (~32%), constipation (~19%), headache (~17%), vomiting (~10%), dizziness (~10%), insomnia (~9%), dry mouth (~8%), diarrhea (~7%). Serious (rare): seizures (risk increases at doses above 32/360 mg daily or with high-fat meals, which raise systemic exposure), increased blood pressure and heart rate (most pronounced in the first three months), hepatotoxicity, angle-closure glaucoma, severe allergic reactions, hyponatremia/SIADH, activation of mania in bipolar patients. Boxed warning: suicidal thoughts and behaviors — bupropion is a member of the antidepressant class and carries the class-wide boxed warning for increased risk of suicidal ideation in children, adolescents, and young adults; monitor all patients for emergence or worsening of depression and suicidality, especially during initiation and dose changes. Contraindicated in patients with uncontrolled hypertension, seizure disorders, anorexia or bulimia, use of other bupropion-containing products, chronic opioid use or acute opiate withdrawal (naltrexone will precipitate withdrawal), abrupt discontinuation of alcohol, benzodiazepines, barbiturates or antiepileptic drugs, or current or recent (within 14 days) MAOI use. Pregnancy is no longer a listed contraindication, but the label says to stop Contrave when pregnancy is recognized.[1][2]

Nothing above is the full list. Your prescriber can give you the complete safety picture, and every adverse reaction on record sits in the current FDA prescribing information[1].

Clinical Trial Results

Contrave's FDA approval was supported by four pivotal 56-week phase 3 trials in the Contrave Obesity Research (COR) program. COR-I (Greenway FL et al., Lancet 2010, PMID 20673995; N=1,742 adults at BMI 30-45, or BMI 27-45 alongside dyslipidemia or hypertension) put mean weight loss at 6.1% on the naltrexone SR 32 mg with bupropion SR 360 mg combination, against 1.3% on placebo, and 48% of patients on the maintenance dose lost ≥5% body weight vs 16% on placebo. COR-II (Apovian CM et al., Obesity 2013, PMID 23408728; N=1,496) confirmed the COR-I efficacy in a second randomized trial of the 32/360 mg dose, with mean weight loss of 6.4% versus 1.2% placebo and 50.5% achieving ≥5% loss versus 17.1%. COR-Diabetes (Hollander P et al., Diabetes Care 2013, PMID 24144653; N=505 adults with type 2 diabetes) showed 5.0% weight loss vs 1.8% placebo plus a 0.6 percentage-point greater HbA1c reduction at 56 weeks. COR-BMOD (Wadden TA et al., Obesity 2011, PMID 20559296; N=793) tested Contrave layered onto an intensive behavior-modification program and produced 9.3% weight loss vs 5.1% with placebo plus behavior modification — the largest absolute weight-loss effect in the COR program, attributable to the added behavioral arm. Across all four trials, placebo-subtracted weight loss was approximately 4-5% body weight, substantially below the 11-15% placebo-subtracted weight loss seen in modern GLP-1 trials (STEP-1, SURMOUNT-1).[2]

Source: Published clinical trial data (STEP / SURMOUNT trial series) — see the Sources panel below for full citations.

Where can you get Contrave?

No seller in our register lists Contrave with a price. It is filled by retail pharmacies on a prescription. The Contrave cost page has what the manufacturer charges.

No seller in the register publishes a price for Contrave. An FSA or HSA will generally cover the prescription under IRS Publication 502[3].

Short verdict pages setting Contrave against the other GLP-1 options, working from the trial results, the dose ladders on each label, and what the manufacturers charge today.

See all drug-vs-drug verdicts.

Longer pieces written here, built on the trial papers themselves, checked against the FDA label, and argued rather than summarized.

Frequently Asked Questions

FDA-approved for chronic weight management in adults with obesity, or overweight with at least one weight-related comorbidity (September 10, 2014). Originally developed by Orexigen Therapeutics; Orexigen filed Chapter 11 in 2018 and the Contrave assets were acquired by Nalpropion Pharmaceuticals (a joint venture of Pernix Therapeutics and a Highbridge-led investor group). Nalpropion was subsequently rolled up into Currax Pharmaceuticals. Azurity Pharmaceuticals announced it had acquired Contrave in June 2026; Drugs@FDA now lists Azurity as sponsor of NDA 200063. Not FDA-approved for pediatric use.
What you pay for Contrave turns on who is selling it and in what form. Uninsured, the branded product runs roughly $1,000 to $1,600 a month; compounded versions through telehealth sellers usually land between $129 and $400. The table above carries the current figures from our register. Before you commit, check whether a manufacturer savings program applies to you.
Common (≥5% and ≥1.5× placebo in pooled phase 3 trials): nausea (~32%), constipation (~19%), headache (~17%), vomiting (~10%), dizziness (~10%), insomnia (~9%), dry mouth (~8%), diarrhea (~7%). Serious (rare): seizures (risk increases at doses above 32/360 mg daily or with high-fat meals, which raise systemic exposure), increased blood pressure and heart rate (most pronounced in the first three months), hepatotoxicity, angle-closure glaucoma, severe allergic reactions, hyponatremia/SIADH, activation of mania in bipolar patients. Boxed warning: suicidal thoughts and behaviors — bupropion is a member of the antidepressant class and carries the class-wide boxed warning for increased risk of suicidal ideation in children, adolescents, and young adults; monitor all patients for emergence or worsening of depression and suicidality, especially during initiation and dose changes. Contraindicated in patients with uncontrolled hypertension, seizure disorders, anorexia or bulimia, use of other bupropion-containing products, chronic opioid use or acute opiate withdrawal (naltrexone will precipitate withdrawal), abrupt discontinuation of alcohol, benzodiazepines, barbiturates or antiepileptic drugs, or current or recent (within 14 days) MAOI use. Pregnancy is no longer a listed contraindication, but the label says to stop Contrave when pregnancy is recognized.
Contrave is prescription-only, so someone licensed has to write it — your own doctor, an endocrinologist, or one of the telehealth sellers above. For compounded versions the telehealth route is usually both quicker and cheaper out of pocket than a traditional pharmacy.
Sources & methodology — as of November 2026
  1. 1.FDA — Wegovy (semaglutide) Approval History via Drugs@FDA— U.S. Food & Drug Administration.
  2. 2.STEP 1 Trial — Once-Weekly Semaglutide in Adults with Overweight or Obesity (Wilding JPH et al.)— New England Journal of Medicine.PMID: 33567185.
  3. 3.IRS Publication 502 — Medical and Dental Expenses (HSA/FSA eligibility)— Internal Revenue Service.