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Posted on May 30th, 2018

Lucemyra gets FDA nod for managing opioid withdrawal symptoms

Lucemyra gets FDA nod for managing opioid withdrawal symptoms

To manage the uncomfortable opioid withdrawal symptoms among adults undergoing treatment for opioid use disorders (OUD), the US Food and Drug Administration (FDA) recently approved the use of lofexidine hydrochloride, which will be marketed as Lucemyra.

Manufactured by specialty pharma U.S. WorldMeds, Lucemyra is the first and only non-opioid medication directed at tackling the opioid withdrawal symptoms. The medicine would be available in America from August 2018.

Earlier, the FDA Psychopharmacologic Drugs Advisory Committee had approved lofexidine hydrochloride in March 2018 after a priority review.

Used for alleviating the physical symptoms of withdrawal from heroin and other opioids,  lofexidine is an adrenergic receptor agonist. It can conceal the neurochemical efflux that triggers acute and painful symptoms of opioid withdrawal. The FDA approved the drug on the basis of data submitted by the manufacturer from two randomized, double-blind, placebo-controlled clinical trials and numerous studies that support the safety and efficacy of the drug.

The committee voted 11-1 to upkeep lofexidine’s secondary indication; however, some committee members asserted that the drug’s recommended dosage be limited to 2.4 mg daily, contrary to the 3.2 mg dose recommended by US WorldMeds. Further the committee also insisted on post-marketing studies. Considering the fact that a higher dose could lead to side effects and adverse events, some committee members suggested that clinicians should be allowed to prescribe higher doses at their discretion. The FDA has also said that Lucemyra is not a treatment, as such, for OUD, but a means to tackle the withdrawal symptoms.

Lucemyra is an important link between withdrawal and treatment

According to Marc Fishman, an assistant professor at the Johns Hopkins University School of Medicine, withdrawal is an important link that determines the subsequent steps in addiction treatment and Lucemyra would act as an essential tool to help people overcome their withdrawals.

Despite the manufacturers touting the advantages of Lucemyra, there are certain safety points that need to be understood.

  • Medicine may not completely prevent withdrawal symptoms; however, it would mitigate their severity.
  • Dosage will not cure drug cravings in an individual.
  • Drug is not an opioid and therefore, is not addictive.
  • Lucemyra might interact negatively with benzodiazepines, barbiturates and alcohol, producing harmful side effects.
  • It is important for practitioner to understand the health history of an individual before prescribing the drug.
  • Common side effects of taking Lucemyra include sleepiness, dry mouth, lightheadedness, slow heart rate, dizziness and low blood pressure among others.
  • Dosage of the drug should be monitored closely by a health care practitioner.

Opioid withdrawal symptoms can be managed

Individuals battling an addiction to opioids may experience acute opiate withdrawal symptoms when the dosage of the drug is suddenly reduced or entirely removed. Some of the opioid withdrawal symptoms include feeling sick, stomach cramps, muscle spasms/twitching, numbness, pounding heart, muscular tension, aches/pains, yawning, runny eyes and a disturbed sleeping pattern, among others.

Drug addiction is damaging to the mental, physiological and emotional health of a person. However, with early intervention and treatment, it is possible to gain sobriety. The first step in any treatment plan is getting rid of the toxins accumulated in the body with years of substance use that can be done through natural assisted detox (NAD).

In case you know someone battling an addiction to drugs or any other substance, contact the Arizona Detox Helpline. We have access to specialized detox treatment centers in Arizona. We can help you connect with some of the best detox centers offering NAD treatment for addiction in Arizona. Call us at our 24/7 detox helpline number 866-593-8453 or chat online with one of our experts for further information.