About the treatment
The drug—lofexidine hydrochloride, which will be marketed as Lucemyra—is an oral treatment designed to lessen the severity of opioid withdrawal symptoms by reducing the release of norepinephrine in the autonomic nervous system. According to FDA, norepinephrine is believed to play a role in opioid withdrawal symptoms.
Lucemyra is approved to treat opioid withdrawal symptoms for up to 14 days. According to FDA, the drug alone is not a treatment for opioid use disorder. However, the agency said Lucemyra could be used as part of a broader treatment plan for opioid use disorder.
According to STAT News, experts say the drug could serve as an important bridge to support some forms of medication-assisted treatment (MATs). For instance, according to STAT News, some MATs, such as buprenorphine or methadone, are opioids and treat both the addiction and ease withdrawal symptoms. But others, like Vivitrol, are non-opioids. While the non-opioids present no risk for diversion or misuse, Vivitrol requires at least a week of detox, during which time patients can experience withdrawal symptoms including, anxiety, diarrhea, drug cravings, muscle aches, nausea, runny nose, sleep problems, and sweating. But, according to STAT News, Lucemyra may be able to ease those symptoms.
Since Lucemyra is not an opioid, providers will be able to it without a waiver.
While misuse is not a potential side effect, FDA said Lucemyra was associated with cases of fainting and that its effect on the heart's electrical activity can increase a person's risk of abnormal heart rhythms. The drug's most common side effects include low blood pressure, slow heart rate, and sleepiness, according to FDA.
Lucemyra is expected to be commercially available on the U.S. market in August, US WorldMeds said in a release.
Basis for approval
FDA approved Lucemyra based on two randomized, double-blind, placebo-controlled clinical trials involving 866 adults who met the Diagnostic and Statistical Manual-IV criteria for opioid dependence. According to FDA, more people treated with Lucemyra completed the treatment period and reported less severe withdrawal symptoms than those treated with the placebo.
The studies did not establish whether Lucemyra is safe and effective treatment in children or adolescents under 17. As such, FDA is requiring 15 post-marketing studies for Lucemyra to evaluate whether the drug is safe and effective for children and long-term use (Al-Muslim, Wall Street Journal, 5/16; Facher, STAT News, 5/16; Roubein, The Hill, 5/16; Krothapalli, Reuters, 5/16; FDA release, 5/16).
Advisory Board's take
FDA's approval of Lucemyra underscores how rapidly this field is changing, both from a clinical and a reimbursement perspective. For example, drug and medical device manufacturers are investigating numerous possible new treatments, while Congress is in the midst of considering a myriad potential opioid-related bills, many intended to expand access to these burgeoning options.
This rapid industry change has the potential to greatly benefit providers' opioid intervention efforts and gives them new tools to help those suffering from opioid use disorder.
To capitalize on the potential benefits of this time of flux, hospitals and health systems must ensure they have leaders within their organizations tracking updates and implementing appropriate changes to prescription and triage protocols. Physicians can also proactively bring new treatment techniques and research to leadership to demonstrate their commitment to shifting the paradigm on how clinicians are confronting the opioid epidemic.
It is particularly important for providers to be certain that treatment options are used for their intended purpose and according to federal guidelines. Lucemyra, for example, is currently designated as a mechanism to mitigate opioid-related withdrawal symptoms, meaning it is inadequate to serve as a medication-assisted treatment (MAT) option on its own, but could play an important role in bridging the gap to MAT options like naltrexone (which require a week of detox before they can be effective). An added benefit is that Lucemyra, like naltrexone, is a non-opioid, which lowers concerns around drug diversion and eliminates the need for clinicians to receive a waiver before prescribing it.
For more information on providers can construct a comprehensive and proactive opioid response strategy, download our latest research on confronting the opioid epidemic. Next, check out all of our top resources on combatting the opioid epidemic here.