The Food and Drug Administration recently approved Lucemyra after an overwhelming 11-2 vote was given in favor of the drug by the Psychopharmacologic Drugs Advisory Committee. Lucemyra (chemical name lofexidine) will be the first non-opioid medication approved specifically to address symptoms of opioid withdrawal. The vote was given after two placebo-controlled trials showed results indicating Lucemyra helped alleviate severe withdrawal symptoms. Patients in the clinical trials were also more likely to complete a seven day detoxification period.
Usually, patients attempting to withdraw from opioids use the medications such as morphine and buprenorphine to taper off. With Lucemyra, patients can now avoid further usage of opioids and more easily transition from drug use to Vivitrol, the medication that entirely blocks the opioid receptors from being activated by drugs. Unlike alcohol and benzos, opioid withdrawal is not life-threatening. However, that doesn’t mean it isn’t painful or terrifying to those facing it. Lucemyra could possibly offer a way out for more addicts seeking recovery.
What Is Lucemyra?
Lucemyra (lofexidine) is known as a selective alpha 2 adrenergic receptor. Essentially, what this means is that the drug reduces the body release of adrenal chemicals. This chemical in the brain, known as norepinephrine, is produced by the brain in response to threats. Think of it as a fight or flight chemical. If an opioid substance is suddenly removed from a body that has grown accustomed to its presence, the body begins overproducing norepinephrine. You can imagine how unhelpful these stressful adrenaline chemicals would be to someone.
With lofexidine, doctors noticed a significant reduction in the amount of norepinephrine produced in the brain by people undergoing withdrawal. The study only compared the effects of Lucemyra compared to a placebo, so there’s no data on its efficacy vs. using an opioid taper. What we do know is that while using a milder opioid such as Methadone or Suboxone, a patient may run the risk of becoming addicted to the taper medication.
What’s great about the drug is that it can also be administered for typical treatment in conjunction with opioids for pain relief. For example, if someone suffered a severe back injury and was leery of using pain medication, Lucemyra could be presented as a safe adjunct medicine to include in their prescription. It wouldn’t require as much certification as opioid medication either.
Official representatives from the US WorldMeds has called the FDA’s approval a milestone in addressing aspects of the opioid crisis. Lucemyra has vast potential for those seeking an injectable treatment option using naltrexone, which requires the patient to be completely opioid-free prior to administering. Scientists recommend that Lucemyra be used during the peak of withdrawal symptoms which occur roughly five to seven days after the last time opioids were ingested. Currently, Lucemyra is available only in tablet form.
Lucemyra is currently produced by the contract manufacturing organization Catalent Pharma Solutions at its Kentucky based facility here in the U.S.
The Timeline for Opioid Withdrawal
Opiates disrupt our brain’s natural abilities to regulate and respond to pain stimuli. By producing a euphoric high that throws our balance out of whack, opioids can inflict some pretty painful side effects during the comedown.
When an opioid enters your body, it targets your central nervous system, which contains opioid receptors and controls the brain, cardiovascular, and breathing systems in the body. For this reason, withdrawals can produce adverse side effects in all areas affected by these processes: Heart rate, blood pressure, skin temperature, breathing rate and emotions.
Symptoms of an opioid withdrawal typically start within 6-12 hours after the last time the drug is used. For long lasting or high dosage of opiates, these effects can begin appearing up to 30 hours after the last usage. Symptoms include:
- Running nose
- Overactive sweat pores
- Muscle pain
- Excessive yawning
- Elevated heart rate
These symptoms constitute the first phase of opioid withdrawal, and will gradually give way to the peak symptoms, roughly 72 hours around the last time an opioid was consumed. These symptoms are much more severe and can feel similar to a cold or flu. These symptoms constitute the worst of the withdrawals and will gradually abate in less than a week. During this time, expect to experience:
- Physical Illness (Vomiting)
- Muscle Pains
- Stomach Cramps
- Intense Cravings
- Mood Changes
Post-Acute Withdrawal Symptoms
For some recovering addicts, post-withdrawal symptoms may linger for days, weeks, and months following detoxification. Post-Acute Withdrawal Symptoms are dependent on the body weight, gender, and level of drug usage that the addict had. PAWS are reported as often as up to two years following detox and are considered much milder, but still hazardous, compared to initial withdrawal symptoms. These include:
- Mood Swings
- Low Energy
- Thought Fog
- Loss of Focus
- Chronic Pain
Rerouting Reward Pathways in the Brain
In 2016, Stanford scientists were able to pinpoint the nerve centers in the brain responsible for triggering other powerful withdrawal symptoms. They researched a cluster of neurons in the brain thought to be associated with rewards. By studying the effects of chronic drug use using morphine-addicted mice, scientists were able to identify the specific neural pathway that activated withdrawal responses in the brain. Using surgery, the scientists successfully reverted the pathway to a lesser potency, eliminating the majority of withdrawal symptoms in mice.
This type of manipulation is still a long ways from being approved for human usage, but scientists are optimistic. The only downside is that downgrading the efficacy of this neural pathway could significantly damage our natural abilities to respond in fight or flight modes of thinking.
Looking To The Future
Detoxification can be one of the most challenging phases of recovery, but it doesn’t need to be a frightening experience. When done in a safe and supportive environment, and with the support of medication, recovery becomes an easier feat to achieve. Reach out to drug and rehab treatment centers near you to find caring providers that can help you safely and successfully live a life free from dependency on mind-altering substances.
Jun 5, 2018
Posted in: Drug