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FDA approves first non-opioid drug to treat opioid withdrawal symptoms

17 May 2018

Patients usually manage withdrawal symptoms by switching the opioid with another medication, or by using therapy.

On May 16, the Food and Drug Administration (FDA) approved of the first non-opioid treatment for adults suffering from opioid withdrawal symptoms. "The lofexidine data demonstrate that, compared with placebo, study participants treated with LUCEMYRA experienced less severe withdrawal symptoms and were significantly more likely to complete opioid withdrawal treatment". These symptoms of opioid withdrawal occur both in patients who have been using opioids appropriately as prescribed and in patients with OUD. But they can become highly addictive, even after the original injury has healed.

Historically, opioid withdrawal is managed by substituting a different opioid and slowly reducing the dosage over time.

Lucemyra, manufactured by Kentucky-based US WorldMeds, is only approved for treatment for up to 14 days. "We're developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms".

Despite public pronouncements on the need to cut back on opioid prescriptions and to punish drug dealers more harshly, administration critics said they have yet to see any concrete plans from the White House to battle the crisis.

It will be the first drug in America to directly mitigate symptoms of withdrawal, rather than targeting their addiction.

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. Scientists believe that this chemical greatly attributes to the majority of opioid withdrawal symptoms. Some patients received Lucemyra, and some patients received a placebo. The symptoms can inflict patients who are using opioids as instructed by a physician, and those patients who are addicted to it. Common side effects include a slow heart rate, low blood pressure, and sleepiness. Additional animal safety studies will be required to support longer-term use (such as during a gradual opioid taper in pain patients discontinuing opioid analgesics) and use in children. Additionally, an independent FDA advisory committee supported the approval at a meeting in March.

Opioids were involved in more than 42,000 overdose deaths in 2016, the past year for which data was available, according to the U.S. Centers for Disease Control and Prevention. There are several drugs on the market that can be used to treat the overall disorder, but some of them are hard to access.

Privately held US WorldMeds said it had not yet set a price for Lucemyra. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA approves first non-opioid drug to treat opioid withdrawal symptoms