Lofexidine

Overview

Lofexidine is a non-opioid centrally acting alpha2-adrenergic receptor agonist that was first approved for the treatment of opioid withdrawal in the United Kingdom in 1992. It was first studied for use as an antihypertensive in 1980, but its researched was stopped as it was found less effective for the treatment of hypertension than clonidine. Lofexidine was then repurposed for the treatment of opioid withdrawal, as it was seen to be more economical and have fewer side effects than clonidine. Lofexidine was developed by US Woldmeds LLC and it was approved by the FDA on May 16, 2018.

Indication

Lofexidine is indicated for mitigation of symptoms associated with acute withdrawal from opioids and for facilitation of the completion of opioid discontinuation treatment. It is the first non-opioid medication for the symptomatic management of opioid discontinuation. Opioid withdrawal syndrome is a debilitating manifestation of opioid dependence. This condition is extremely unpleasant lasting several days with some of the main features being abdominal pain, nausea, diarrhea, mydriasis, lacrimation, and piloerection. These symptoms are often observed after abrupt reductions in the opioid dose and can be resolved by re-administration of the opioid.

Associated Conditions

Abrupt opioid withdrawal

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects	2024/12/02	NCT06711640	Phase 1	Withdrawn	USWM, LLC (dba US WorldMeds)
Treatment of Withdrawal Symptoms and Prevention of Relapse in Patients With Tramadol Abuse	2022/10/06	NCT05569031	Phase 4	Completed	Zagazig University
Evaluating Buspirone to Treat Opioid Withdrawal	2022/08/23	NCT05511909	Phase 2	Recruiting	Johns Hopkins University
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder	2021/09/22	NCT05053503	Not Applicable	Completed	Spark Biomedical, Inc.
Assessing a Clinically-meaningful Opioid Withdrawal Phenotype	2021/08/31	NCT05027919	Phase 2	Recruiting	University of Maryland, Baltimore
Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans	2020/04/24	NCT04360681	Phase 2	Recruiting	Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
An Innovative Intervention for OUD Treatment	2020/03/27	NCT04325659	Phase 2	Recruiting	Johns Hopkins University
Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal	2020/01/06	NCT04218240	Phase 2	Completed	University of Pennsylvania
A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidine) Tablets and the Effect of Food on the Bioavailability of the Lofexidine Granules for Reconstitution	2019/12/06	NCT04188730	Phase 1	Completed	USWM, LLC (dba US WorldMeds)
Lofexidine for Adults Undergoing Lumbar Spine Surgery	2019/10/15	NCT04126083	Phase 4	Completed	Mayo Clinic

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Lucemyra	USWM, LLC	78670-050	ORAL	0.2 mg in 1 1	9/30/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Spark Biomedical Completes Enrollment in Two Pivotal Neurostimulation Trials for Opioid Use Disorder and Neonatal Withdrawal

5 months ago

Spark Biomedical has completed enrollment for two pivotal clinical trials investigating transcutaneous auricular neurostimulation (tAN) therapy for opioid use disorder in adults and neonatal opioid withdrawal syndrome.

Lofexidine Trial Launched for Neonatal Opioid Withdrawal Syndrome

a year ago

Marshall University is conducting a clinical trial to assess oral lofexidine, a non-opioid medication, for treating Neonatal Opioid Withdrawal Syndrome (NOWS).

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