FDA Approves First Non-Opioid Drug to Treat Withdrawal Sx
- Author: Aubrey Nash May 18, 2018,
May 18, 2018, 9:29
For people who have been diagnosed with opioid use disorder, withdrawal management alone, with or without Lucemyra, is not recommended; Lucemyra should be used as part of a long-term treatment plan created by a healthcare provider. The FDA conceded the endorsement of Lucemyra to Louisville, Ky. - based pharmaceutical organization US WorldMeds LLC, the office said Wednesday.
For those addicted to opioids, quitting cold turkey can be a harrowing experience.
The pill was approved to treat adults for up to two weeks for common withdrawal symptoms like vomiting, diarrhea, muscle pain and agitation.
"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", Gottlieb said in a press release.
"Lucemyra presents an important new tool to help people make it successfully through withdrawal, which is very often critical for linking to ongoing continuing care and next steps in treatment for opioid dependence or addiction", said Marc Fishman, MD, medical director, Maryland Treatment Centers and assistant professor, Johns Hopkins University School of Medicine. "And those who seek assistance may relapse due to continued withdrawal symptoms", the FDA said in a May 16 statement. It is essentially a selective alpha 2-adrenergic receptor agonist. 866 adults participated in the study. Data from the Phase III study revealed that those treated with Lucemyra showed a significant reduction in withdrawal symptoms and demonstrated a longer stay in detoxification treatment when compared to individuals in the placebo group.
"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", Dr. Gottlieb said.
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. This study also said that misuse (but not addiction) of opioids among chronic pain patients can be between 21 to 29 percent. Some patients - or doctors - may prefer an option like Lucemyra to ease withdrawal symptoms, as it the drug does not contain opioids.
The safety and efficacy have not been established in children or adolescents 17 years of age and younger.
The FDA allowed this application Priority Review and Fast Track assignments, and an autonomous FDA warning board bolstered the endorsement of Lucemyra at a gathering held March.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.