FDA New Drug and Biologic Approvals, 2018 Midyear Review

Mary L Windle, PharmD

Disclosures

August 01, 2018

In This Article

Opioid Withdrawal: Lucemyra (lofexidine)

Indication: Indicated for short-term use (up to 14 days) to mitigate abrupt opioid withdrawal in adults.

Mechanism: Centrally acting alpha2-agonist that binds to receptors on adrenergic neurons; this reduces the release of norepinephrine and decreases sympathetic tone.

Dosage:

  • Starting dose: 0.54 mg (three 0.18-mg tablets) PO QID (5-6 hr between doses) during the period of peak withdrawal symptoms (generally the first 5-7 days after last opioid use).

  • Not to exceed a total daily dose of 2.88 mg (16 tablets).

  • No single dose should exceed 0.72 mg (4 tablets).

  • Discontinue with a gradual dose reduction over 2-4 days.

Approval was based on 2 randomized, double-blind, placebo-controlled clinical trials; an open-label study; and clinical pharmacology studies with concomitant administration of either methadone, buprenorphine, or naltrexone. Data showed that compared to patients given placebo, participants treated with lofexidine experienced less severe withdrawal symptoms and were significantly more likely to complete a 7-day opioid discontinuation treatment.

References:

  • Gorodetzky CW, Walsh SL, Martin PR, et al. A phase III, randomized, multi-center, double blind, placebo controlled study of safety and efficacy of lofexidine for relief of symptoms in individuals undergoing inpatient opioid withdrawal. Drug Alcohol Depend. 2017 Jul 1;176:79-88. https://www.ncbi.nlm.nih.gov/pubmed/28527421

  • Law FD, Diaper AM, Melichar JK, et al. Buprenorphine/naloxone versus methadone and lofexidine in community stabilisation and detoxification: A randomised controlled trial of low dose short-term opiate-dependent individuals. J Psychopharmacol. 2017 Aug;31(8):1046-1055. https://www.ncbi.nlm.nih.gov/pubmed/28631527

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