This medication “provides a new option that allows providers to work with patients to select the treatment best suited to an individual’s needs,” said Sharon Hertz, M.D., director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research, in a statement.
The decision to approve Lucemyra was based in part on the results of two randomized, double-blind, placebo-controlled clinical trials of 866 adults who met DSM-IV criteria for opioid dependence and were physically dependent on opioids and undergoing abrupt opioid discontinuation. Participants assigned to Lucemyra and placebo were asked to rate the severity of opioid withdrawal symptoms using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) using one of four response options (none, mild, moderate, and severe), with the SOWS-Gossop total score ranging from 0 to 30 (higher score indicates a greater severity of withdrawal symptoms).
According to the FDA, SOWS-Gossop scores were lower for patients treated with Lucemyra compared with placebo, and more patients completed the studies’ treatment period in the Lucemyra group compared with the placebo group. The most common side effects reported by study participants on Lucemyra included low blood pressure, slow heart rate, sleepiness, sedation, and dizziness. Lucemyra was also associated with a few cases of fainting. When Lucemyra is stopped, patients may experience a marked increase in blood pressure, the agency cautioned.
The long-term effects of Lucemyra will be among several factors evaluated in ongoing postmarketing studies. “Clinical studies will be required to evaluate the safety of Lucemyra in clinical situations where use could be expected to exceed the maximum 14-day treatment period for which the product is currently approved, such as gradual opioid taper; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after lofexidine is stopped,” the agency stated.
According to a press release by US WorldMeds, the manufacturer of Lucemyra, the medication is usually administered in three 0.18 mg tablets taken orally four times daily at five- to six-hour intervals during the period of peak withdrawal symptoms (generally five to seven days following last use of opioids). Lucemyra should be discontinued with gradual dose reduction over two to four days.
Lucemyra is expected to be commercially available in the United States in August 2018, according to US WorldMeds.