"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", FDA Commissioner Dr. Scott Gottlieb said in a statement. 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.
One form of medication-assisted treatment requires that a person have already gone through detox, which is when withdrawal symptoms occur. Announcing the move in a press statement yesterday (May 16), the agency noted that Lucemyra (lofexidine hydrochloride) is meant to help adults who abruptly stop taking the addictive painkillers, and is only approved for treatment for up to two weeks. It is not an addiction treatment but can be part of a longer-term plan. The symptoms can inflict patients who are using opioids as instructed by a physician, and those patients who are addicted to it.
SOWS-Gossop scores were lower for patients treated with Lucemyra versus placebo and more patients in the Lucemyra group completed the treatment period.
Historically, opioid withdrawal is managed by substituting a different opioid and slowly reducing the dosage over time.
Gottlieb also said the FDA will be developing guidance documents for the most efficient path for developing drugs that can be used to treat various types of pain.
Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine.
The FDA granted this application both priority review and fast track designations. The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal.
The new compound itself is not without side effects; Lucemyra can cause dizziness as well as low blood pressure and heart rate. Some patients received Lucemyra, and some patients received a placebo. Lucemyra was additionally connected with a couple of instances of syncope (blacking out). Safety and efficacy in patients younger than 17 has not been established, the agency noted. Specifically, the studies will investigate the safety of Lucemyra in situations where use may last beyond the 14-day recommended treatment period, as well as what the effects may be on blood pressure after the treatment is discontinued.
An independent FDA advisory committee supported approving Lucemyra in March.
The U.S. Food and Drug Administration expedited approval of Lucemyra to help combat the U.S. opioid epidemic. There are several drugs on the market that can be used to treat the overall disorder, but some of them are hard to access.
Manufacturer US WorldMeds said it will market the drug as soon as this summer, under the trade name Lucemyra.