BIOCORRX PHARMS — Lucemyra FDA Review (NDA209229, ORIG 1, 2018)
BIOCORRX PHARMS · 2018 · FDA Review (openFDA)
Report summary
The FDA review recommends approval of Lucemyra (lofexidine HCl) for mitigating opioid withdrawal symptoms in adults, making it the first non-opioid for this indication. Clinical trials (Studies 3002, 3003-1) demonstrated significant reduction in withdrawal symptoms and improved retention compared to placebo. However, safety concerns include dose-dependent hypotension, bradycardia, and QT prolongation, with a 2.4 mg/day dose recommended due to a better safety profile. Nonclinical studies revealed reproductive toxicity, organ pathologies, and potential genotoxicity. Post-marketing studies are required for pediatric use and long-term safety. Dosage adjustments are needed for hepatic/renal impairment, and drug interactions with CYP2D6 inhibitors are noted.
Key findings — cited to the page
| Submit Date | September 26, 2017 | Lucemyra · p.2 |
| Completers in lofexidine group | 10 completers | Study 1020 · p.512 |
| Study design | randomized, multicenter, double-blind, placebo-controlled, multiple-dose, parallel-group study | Study 1020 · p.512 |
| Abuse potential conclusion | inconclusive | Study 1020 · p.512 |
| Proposed indication | Mitigation of symptoms associated with opioid withdrawal Facilitation of completion of opioid discontinuation treatment | US · p.514 |
| Mean difference for VAS High (morphine vs placebo) | 8.16 | Study 1020 · p.523 |
| Completers in placebo group | 5 completers | Study 1020 · p.512 |
| Randomized subjects | 68 subjects | Study 1020 · p.512 |
| Application Type | NDA | Lucemyra · p.2 |
| Application Number | 209229 | Lucemyra · p.2 |
| Priority or Standard | Priority | Lucemyra · p.2 |
| PDUFA Goal Date | May 26, 2018 | Lucemyra · p.2 |
Source: BIOCORRX PHARMS ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →