You’ve reached your first addiction-recovery milestone: you’ve recognized an opioid addiction, and more importantly you’ve chosen to seek help. Perhaps you enter an inpatient treatment center, or you seek outpatient advice from a healthcare professional. A doctor lays out a realistic treatment program, and you feel hopeful as you proceed forward.
But at some point in your journey, the nausea will set in. It may feel like you’re coming down with the flu, only you may have anxiety and perhaps a panic-attack to complement your aching stomach, cramping muscles and heart palpitations. Even with opioid-replacement therapies, some withdrawal symptoms are imminent.
Perhaps they come when you switch to a less-potent opioid, like methadone, or perhaps you’re finally coming off of methadone and opioids entirely. In some way or another, you’re reducing the concentration of opioid drugs in your system, and you’re making progress. You should be very proud of yourself.
And yet, the physical withdrawal symptoms may feel like too much to keep going.
Fortunately, a new FDA-approved non-opioid prescription drug that can help manage the physical effects of quitting opioids is available this month: Lucemyra.
What is Lucemyra?
Lucemyra (lofexidine hydrochloride) is the first non-opioid FDA-approved treatment for managing opioid withdrawal symptoms in the U.S. Often, physicians manage opioid withdrawal symptoms with carefully-prescribed doses of less potent and dangerous opioids, such as buprenorphine and methadone. Lucemyra offers a non-opioid alternative to mitigate withdrawal symptoms, though it is not approved to treat opioid use disorder (OUD) on its own but rather as part of a broader, long-term treatment plan.
Lucemyra is new in the sense that it was only recently approved by the FDA in the U.S. specifically to help treat opioid-withdrawal symptoms. However, the drug itself isn’t new. Lofexidine is prescribed in Europe for hypertension, and a similar drug clonodine treats hypertension in the U.S. In fact, physicians have prescribed clonodine off-label to manage opioid withdrawal symptoms in the U.S. for decades, and with good reason. Numerous studies show both drugs work, although lofexedine causes less hypotensive effects than clonodine [1,2,3].
Does Lucemyra Work?
Both lofexedine and clonodine are central alpha-2 adrenergic agonists. These drugs reduce norepinephrine and sympathetic activity in the nervous system. Chronic opioid use does the opposite, suppressing norepinephrine release and sympathetic activity. When an addict goes through acute withdrawal, the abrupt increase in norepinephrine causes many of the symptoms associated with withdrawal. So, by moderating sympathetic overactivity during acute withdrawal, lofexedine and clonidine can help mitigate withdrawal symptoms .
To test Lucemyra’s safety and efficacy, the FDA conducted two randomized, double-blind clinical trials. The trials included 866 adults that met the diagnostic criteria for opioid dependence and underwent abrupt opioid discontinuation. Subjects took either lofexedine or a placebo during discontinuation of opioids and rated their withdrawal symptoms using the Short Opiate Withdrawal Scale (SOWS), a 10-item questionnaire that evaluates opioid withdrawal symptom severity.
The 10 withdrawal symptoms included on the SOWS scale were:
- Feeling sick
- Feeling cold
- Stomach cramps
- Muscle spasms
- Heart palpitations
- Muscle tension
- Aches and pains
- Runny eyes
- Sleep disturbances
The patients rate the severity of each symptom with 4 response options: none, mild, moderate, and severe. Their answers are then scored from 0 to 30, with a higher score indicating higher severity of withdrawal symptoms.
Subjects given Lucemyra had lower SOWS-Gossop scores compared to those given the placebo. Notably, those in the Lucemyra groups were also more likely to complete the treatment period of the studies than those in the placebo groups.
Limitations of Lucemyra
The FDA specifies that it approves Lucemyra for up to a maximum of 14 days in patients aged 17 and older. They also state that, while mitigating physical withdrawal symptoms, Lucemyra may not completely prevent them. It also does not help coping with cravings and urges.
The following are potential side effects of the drug:
- Hypotension (low blood-pressure) followed by a marked increase of blood pressure upon cessation of the drug
- Bradycardia (slow heart-rate)
- Somnolence (sleepiness)
- Sedation and dizziness
- (A few rare cases of) Fainting
- A potential increase in the risk of abnormal heart rhythms
How Much Does Lucemyra Cost?
Some health insurance plans may provide coverage for Lucemyra. Anyone who is paying out of pocket, however, could expect to pay nearly $2,000 for a 96-pill prescription, according to a pharmaceutical price catalog. Clonodine, which has been used off-label for decades to manage similar symptoms, costs about $20 for 100 oral tablets. Regardless of your method of payment, remember to discuss all possible options with your healthcare provider.