wnol.info June 23 2018


FDA OKs first non-opioid treatment for opioid withdrawal

June 23 2018, 04:34 | Rex Rios

FDA OKs first non-opioid treatment for opioid withdrawal

FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

Clinical studies will be required to evaluate the safety of Lucemyra in clinical situations where use could be expected to exceed the maximum 14-day treatment period for which the product is now approved, such as gradual opioid taper; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after lofexidine is stopped.

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

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. These side effects of opioid withdrawal happen both in patients who have been utilizing opioids suitably as endorsed and in patients with OUD.

Now, the FDA is asking for input from chronic pain patients again to learn more about the "impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments".

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"Which is why patients may often not be able to go through the process without being an inpatient".

Lucemyra (lofexidine hydrochloride) was originally meant to be a hypertension drug. 866 adults participated in the study. SOWS-Gossop scores were brought down for patients treated with Lucemyra contrasted with fake treatment, and more patients finished the treatment time of the investigations in the Lucemyra amass contrasted with fake treatment. Extra creature security studies will be required to help longer-term utilize, (for example, amid a progressive opioid decrease in torment patients stopping opioid analgesics) and use in youngsters. The drug can also elevate the risk of abnormal heart rhythms. Studies will also take place in pediatric patients, including on newborns with neonatal opioid withdrawal and on different age groups of children. When Lucemyra is stopped, patients can experience a marked increase in blood pressure. Safety and efficacy in patients younger than 17 has not been established, the agency noted.

"There are many people who are physically dependent, meaning if you stop it, you're going to get withdrawal symptoms", but those people may not be to the point of negative social behavior, such as stealing things or ruining relationships, said Dr. Mark Pirner, senior medical director of Clinical Research and Medical Affairs for US WorldMeds. The FDA mandated an additional 15 post-market studies of the drug, including more pre-clinical safety trials that will be necessary for label expansions. An advisory committee this March had approved Lucemyra and had advised the FDA accordingly.



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