First Nonopioid Treatment To Ease Withdrawal Symptoms Approved By FDA
Regulators say that Lucemyra is not an addiction medicine but that it can be part of a longer-term treatment plan. "The physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction," says Dr. Scot Gottlieb, the FDA's commissioner.
The Associated Press:
FDA Approves 1st Nonopioid Drug To Ease Withdrawal Symptoms
Federal regulators on Wednesday approved the first nonopioid treatment to ease withdrawal from quitting addictive opioids. The U.S. Food and Drug Administration expedited approval of Lucemyra to help combat the U.S. opioid epidemic. Two-thirds of drug overdose deaths in 2016 involved opioids, mostly fentanyl, heroin and prescription painkillers. The pill was approved to treat adults for up to two weeks for common withdrawal symptoms like vomiting, diarrhea, muscle pain and agitation. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA. (Johnson, 5/16)
The Wall Street Journal:
FDA Approves First Nonopioid Treatment For Opioid Withdrawal Symptoms
The FDA granted the approval of Lucemyra to Louisville, Ky.-based pharmaceutical company US WorldMeds LLC, the agency said Wednesday. The company also develops products for patients with Parkinson’s disease, malignant hyperthermia and other medical conditions. “We’re developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms,” FDA Commissioner Scott Gottlieb said in prepared remarks. “We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction.” (Al-Muslim, 5/16)
Los Angeles Times:
FDA Approves Lucemyra To Treat Symptoms Of Opioid Withdrawal And Help Patients Overcome Addiction
"The physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction," said Dr. Scot Gottlieb, the FDA's commissioner. "The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms." (Kaplan, 5/16)
Stat:
FDA Approves Drug Meant To Mitigate Symptoms Of Opioid Withdrawal
The Food and Drug Administration on Wednesday approved for the first time a drug meant to mitigate the symptoms of opioid withdrawal — rather than an underlying dependency — giving American physicians a new tool to help patients begin treatment. The drug, lofexidine, will be manufactured by Kentucky-based US WorldMeds and marketed as Lucemyra. (Facher, 5/16)
In other news on the crisis —
Modern Healthcare:
Medicaid Payment For Opioid Treatment Embroiled In Politics Over Loosening Restrictions
In Cincinnati, wait times for opioid addicts seeking residential treatment have dropped as the city's providers are banding together to manage the barrage of cases across different settings.In January, Mercy Health partnered with 10 outpatient treatment centers. The hospital offers short-term detox stays for patients, then the clinics take over and manage the long-term treatment, nearly on demand. After they have stabilized, patients can decide whether they want residential treatment or outpatient care. (Luthi, 5/16)
CQ:
Ways And Means Advances Opioid Bills
The House Ways and Means Committee on Wednesday advanced four bipartisan opioid packages that are expected to move with other House bills. The action comes a day before the House Energy and Commerce Committee intends to hold its own opioid-related markup. The four legislative opioid packages include a variety of measures by members on both sides of the aisle. They focus on combating the crisis through prevention, provider education, beneficiary education, and treatment options. (Raman, 5/16)
The Star Tribune:
Kidney Stone Pain Overtreated In ER But Lighter Approach Just As Effective, Data Say
When kidney stone patients come into emergency rooms, complaining that the pain is worse than childbirth, or falling off a roof, doctors often have been persuaded to overtreat them with potent opioid painkillers. ... Trouble is, new data suggest that another common medication works equally well, and that prescriptions of opioids create problems ranging from nausea to addiction for these patients. (Olson, 5/16)
