In a statement, FDA Commissioner Scott Gottlieb said the approval was a positive development in the agency's continued effort to help people overcome opioid addiction.
For each withdrawal symptom, patients were asked to rate the severity using 4 response options (none, mild, moderate and severe) with the SOWS-Gossop total score ranging from 0-30-a higher score indicated a greater withdrawal symptom severity. 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 drug is not for treating opioid use disorder but can be used as part of a long-term plan for managing it, the agency added. Lucemyra was approved to treat withdrawal symptoms for up to two weeks.
Now, the FDA is asking for input from chronic pain patients again to learn more about the "impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments".
Other clinical studies will include newborns with neonatal opioid withdrawal and pediatric patients of different age groups who have opioid withdrawal related to stopping medically-prescribed opioids.
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. It reduces the release of norepinephrine, a hormone believed to play a key role in triggering withdrawal symptoms. To prevent such symptoms, doctors typically recommend slow withdrawal from the drug, the FDA said. When Lucemyra is stopped, patients can experience a marked increase in blood pressure.
The FDA is requiring 15 postmarketing examines, including both creature and human examinations. Safety and efficacy in patients younger than 17 has not been established, the agency noted.
Human studies are needed to find out how safe lofexidine is if it's used for longer than the maximum 14-day treatment period, to get more data on how safe it is for the liver, and to further study its effects on blood pressure after it is stopped.
An independent FDA advisory committee supported approving Lucemyra in March.
The U.S. Sustenance and Drug Administration today affirmed Lucemyra (lofexidine hydrochloride) for the alleviation of withdrawal side effects to encourage unexpected suspension of opioids in grown-ups. There are several drugs on the market that can be used to treat the overall disorder, but some of them are hard to access.