FDA OKs first non-opioid treatment for opioid withdrawal

17 May, 2018, 09:40 | Author: Earnest Bishop
  • The FDA approved a nonopioid drug to assist with opioid withdrawal symptoms as a tool to fight the U.S. opioid crisis

On May 16, the Food and Drug Administration (FDA) approved of the first non-opioid treatment for adults suffering from opioid withdrawal symptoms.

"As part of our commitment to support patients struggling with addiction, we're dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids", said FDA Commissioner Scott Gottlieb, M.D.

Although researchers are confident that Lucemyra will help some patients manage symptoms, there are some concerns. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. And those who seek assistance may relapse due to continued withdrawal symptoms. "The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that's sometimes associated with the use of medication-assisted treatments". Such signs and responses are expected to occur in varying degrees, both in patients who used opioids correctly and in patients with OUD. It is not approved as a treatment for opioid use disorder. Scientists believe that this chemical greatly attributes to the majority of opioid withdrawal symptoms. The safety and efficacy of Lucemyra was supported by two randomized, double-blind, placebo-controlled clinical trials of 866 adults meeting Diagnostic and Statistical Manual-IV criteria for opioid dependence who were physically dependent on opioids and undergoing abrupt opioid discontinuation. These symptoms include feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia/problems sleeping. "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". Common side effects include a slow heart rate, low blood pressure, and sleepiness. Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms. Some patients received Lucemyra, and some patients received a placebo. More studies are being planned to understand the safety and efficacy of Lucemyra in children or adolescents under 17 years of age.

"Most opiate overdose deaths occur in people who have just detoxed".

The FDA is requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct more studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids.

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The FDA said that Lucemyra is only approved for up to 14 days.

These come on within hours of a drug-dependent person stopping or cutting their dosage of opioids - whether it's prescribed or sought out for abuse.

The application was granted priority review and fast track designations, and an independent FDA advisory committee supported the approval of Lucemyra at a meeting held in March.

Opioids were involved in more than 42,000 overdose deaths in 2016, the a year ago 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.



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