Monday, 17 December, 2018


FDA OKs first non-opioid treatment for opioid withdrawal

FDA OKs first non-opioid treatment for opioid withdrawal FDA OKs first non-opioid treatment for opioid withdrawal
Patty Aguilar | 18 May, 2018, 00:18

Two-thirds of drug overdose deaths in 2016 involved opioids, mostly fentanyl, heroin and prescription painkillers.

Patients usually manage withdrawal symptoms by switching the opioid with another medication or by using therapy. It is not a treatment for opioid use disorder but can be used as part of a broader, long-term treatment plan for managing it, the FDA said in a news release. Additionally, the therapy has not been approved to treat opioid use disorder, but is meant to be used as part of a long-term treatment plan for the condition. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. It is approved for treatment for only up to 14 days.

Other clinical studies will include newborns with neonatal opioid withdrawal and pediatric patients of different age groups who have opioid withdrawal related to stopping medically-prescribed opioids. Its safety and how well it works is not known in people younger than 17.

Lucemyra, a selective alpha 2-adrenergic receptor agonist, works by reducing the release of norepinephrine and decreasing sympathetic tone; the actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal.

The drug, which will be available in pharmacies across the country in August, was approved under Priority Review, which is granted to submissions for medications that would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions, according to US WorldMeds. Scientists believe that this chemical greatly attributes to the majority of opioid withdrawal symptoms. Adverse side effects included low blood pressure or symptoms such as lightheadedness, slow heart rate, dizziness, sleepiness, feeling faint at rest or when standing up, and dry mouth, said the release.

The data showed patients treated with Lucemyra reported lower SOWS-Gossop scores vs placebo. Lucemyra was additionally connected with a couple of instances of syncope (blacking out). Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms.

The FDA is requiring 15 post-marketing studies - or studies that happen after a drug is approved.

Human studies are needed to find out how safe lofexidine is if it's used for longer than the maximum 14-day treatment period, to get more data on how safe it is for the liver, and to further study its effects on blood pressure after it is stopped.

The U.S. Food and Drug Administration expedited approval of Lucemyra to help combat the U.S. opioid epidemic. The agency will also continue to evaluate how drugs now on the market are used, in both medical and illicit settings, and take regulatory action where needed.

The drug, which has been used in the United Kingdom for more than two decades now, is made by Louisville, KY-based US WorldMeds.

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