tiptrot.com
tiptrot.com May 26, 2018


FDA approves first non-opioid to treat withdrawal symptoms

18 May 2018, 09:31 | Nichole Osborne

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

"Lucemyra will reduce the symptoms, but it won't completely eliminate them, and the best candidate will have a plan with their health care provider for during withdrawal and whatever is required after", Pirner said.

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

In patients using opioid analgesics appropriately as prescribed, opioid withdrawal is typically managed by slow taper of the medication, which is meant to avoid or lessen the effects of withdrawal while allowing the body to adapt to not having the opioid. The symptoms can inflict patients who are using opioids as instructed by a physician, and those patients who are addicted to it. At present the new drug has been granted Priority Review and Fast Track approval.

While there are now some other approved drugs that mitigate withdrawal symptoms, many are themselves opioids, such as buprenorphine, or target specific symptoms alongside underlying opioid dependency.

The FDA's approval of Lucemyra is supported by two randomized, double-blind, placebo-controlled clinical trials, an open-label study and clinical pharmacology studies with concomitant administration of either methadone, buprenorphine or naltrexone. Now, thanks to an FDA approval for US WorldMeds' Lucemyra, they'll have the first drug created to fight those symptoms. Compared to placebo, Short Opiate Withdrawal Scale of Gossop scores were found to be lower for patients treated with Lucemyra, and more patients finished the treatment in the Lucemyra group versus the placebo group. It also does not stop patients from craving opioids.


Typical patients will receive three tablets taken orally four times a day at five- to six-hour intervals during the period of peak withdrawal symptoms. Lucemyra impacts the heart's electrical action, which can expand the danger of unusual heart rhythms. When Lucemyra is stopped, patients can experience a marked increase in blood pressure.

The safety and efficacy have not been established in children or adolescents 17 years of age and younger.

The FDA requires a further 15 postmarketing studies to check for the safety of the drug.

Patients with chronic pain can attend the FDA's "Patient-Focused Drug Development for Chronic Pain" meeting on July 9 from 10 a.m.to 4 p.m. Patients can attend in person in Maryland or through a webinar by registering online.



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