FDA Approves Drug to Ease Symptoms of Opioid Withdrawal

FDA Approves Drug to Ease Symptoms of Opioid Withdrawal

US WorldMeds announced Wednesday that the U.S. Food and Drug Administration had approved the drug, Lucemyra, to help manage the symptoms of opioid withdrawal.

"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. Lucemyra was approved to treat withdrawal symptoms for up to two weeks.

"We are humbled to bring to the market the first and only non-opioid treatment for the mitigation of withdrawal symptoms - and are grateful for the urgency demonstrated by the FDA in rapidly reviewing and approving this important treatment", US WorldMeds Chief Executive P. Breckinridge "Breck" Jones, said in a news release. For opioids, withdrawal symptoms can include runny noses, sleep problems, sweating, nausea, vomiting and more. "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".

"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.

The federal government and Congress are grappling with how to stem the tide of the opioid epidemic, which has shown no signs of slowing down and is contributing to an estimated 115 American deaths per day. Lucemyra impacts the heart's electrical action, which can expand the danger of unusual heart rhythms. It also does not stop patients from craving opioids. When treatment is stopped, patients can experience a marked increase in blood pressure.

Historically, opioid withdrawal is managed by substituting a different opioid and slowly reducing the dosage over time. Its safety and how well it works is not known in people younger than 17.

Lucemyra is an oral, specific alpha 2-adrenergic receptor agonist that decreases the arrival of norepinephrine. They include both animal and human studies.

The FDA still wants Lucemyra to conduct some safety studies to see the effects on children.

The FDA granted this application Priority Review and Fast Track designations, and an independent FDA advisory committee supported the approval of Lucemyra at a meeting held March.

The drug, called Lucemyra (lofexidine hydrochloride), will also help adults who rely on opioids for pain relief. 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 should be available by the summer.