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Naltrexone hydrochloride 50 mg tablets prescribing information ↗

Drugs@FDA: Revia (naltrexone hydrochloride) application overview ↗

FDA: understanding unapproved use of approved drugs (off label) ↗

FDA: human drug compounding ↗

Cochrane review: low dose naltrexone for active Crohn's disease ↗

A randomised, double-blind, placebo-controlled trial of 6 mg low-dose naltrexone in 99 women with fibromyalgia concluded that the study did not show treatment with low-dose naltrexone was superior to placebo in relieving pain.

A 12-month randomised, double-blind, placebo-controlled trial of LDN 4.5 mg/day in 98 women with fibromyalgia concluded that LDN was well tolerated but did not demonstrate a clinically meaningful benefit over placebo for pain-related outcomes.

A systematic review and meta-analysis of five randomized controlled trials reports that low-dose naltrexone was superior to placebo in alleviating fibromyalgia pain in its primary analysis (SMD -0.61; 95% CI -1.14, -0.08) but not in raising mechanical pain threshold.

A 12-week randomized, double-blind, placebo-controlled trial of 4.5-mg naltrexone in forty adults with active Crohn's disease reports that 88% of naltrexone-treated patients had at least a 70-point decline in CDAI scores compared to 40% of placebo-treated patients (p = 0.009). Its conflict-of-interest statement discloses that two of its authors have intellectual property rights and have a patent for the use of naltrexone in IBD.

A Cochrane review on low dose naltrexone for Crohn's disease concludes that currently there is insufficient evidence to allow any firm conclusions regarding the efficacy and safety of LDN used to treat patients with active Crohn's disease.

A narrative review of 105 low-dose naltrexone studies says early positive findings from uncontrolled studies were rarely replicated in placebo-controlled trials and most available evidence consists of case reports and small feasibility studies. It says LDN is generally safe, inexpensive and well tolerated, with most studies using a daily dose of 4.5 mg, but that current evidence does not support routine clinical use.

The FDA says compounded drugs are not FDA approved, which means the agency does not review their safety, effectiveness or quality before they are marketed.