Lucemyra(Lofexidine hydrochloride)

Psychiatry· 597 cited findings· 1 source document

Company: BIOCORRX PHARMS

What the regulatory reviews say

Lucemyra (Lofexidine hydrochloride) is a drug indicated for the mitigation of symptoms associated with opioid withdrawal and to facilitate the completion of opioid discontinuation treatment. The New Drug Application (NDA 209229) for Lucemyra was submitted on September 26, 2017, and received Priority review, with a review completion date of May 15, 2018.

Efficacy findings from randomized, multicenter, double-blind, placebo-controlled studies indicate that Lofexidine is effective in mitigating opioid withdrawal symptoms. The SOWS-Gossop completer rate at Day 5 was 46% (2.4 mg/day) and 47% (3.2 mg/day) compared to 32% for placebo. The completion rate during the treatment phase (Day 5) was 49% for the lofexidine group versus 33% for placebo. The odds ratio of completing opioid withdrawal was 1.85 and 1.71 versus placebo.

Safety concerns include hypotension, bradycardia, orthostatic hypotension, dizziness, syncope, rebound hypertension, and QT prolongation. Risks associated with the 2.88 mg/day regimen were found to exceed those of the 2.16 mg per day regimen. The abuse potential conclusion was inconclusive. The background risk of major birth defects in the U.S. general population is 2% to 4%, and the background risk of miscarriage is 15% to 20%.

Key figures — cited to the source page

SOWS-Gossop completer rate vs placebo at Day 5 (2.4 mg/day)	46%	BIOCORRX PHARMS — Lucemyra FDA Review (NDA209229, ORIG 1, 20, p.331
SOWS-Gossop completer rate vs placebo at Day 5 (3.2 mg/day)	47%	BIOCORRX PHARMS — Lucemyra FDA Review (NDA209229, ORIG 1, 20, p.331
SOWS-Gossop completer rate for placebo at Day 5	32%	BIOCORRX PHARMS — Lucemyra FDA Review (NDA209229, ORIG 1, 20, p.331
Completion rate during treatment phase (Day 5)	49	BIOCORRX PHARMS — Lucemyra FDA Review (NDA209229, ORIG 1, 20, p.47
Completion rate during treatment phase (Day 5) for placebo	33	BIOCORRX PHARMS — Lucemyra FDA Review (NDA209229, ORIG 1, 20, p.47
Odds Ratio of completing opioid withdrawal vs placebo	1.85	BIOCORRX PHARMS — Lucemyra FDA Review (NDA209229, ORIG 1, 20, p.61
Lofexidine risks	hypotension, bradycardia, orthostatic hypotension, dizziness, syncope, rebound hypertension and QT prolongation	BIOCORRX PHARMS — Lucemyra FDA Review (NDA209229, ORIG 1, 20, p.10
Application Type	NDA	BIOCORRX PHARMS — Lucemyra FDA Review (NDA209229, ORIG 1, 20, p.2

Source documents

BIOCORRX PHARMS — Lucemyra FDA Review (NDA209229, ORIG 1, 2018) (2018)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.