"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. Patients can experience any combination of these symptoms after ceasing opioid use.
In two studies of 866 adults, those given Lucemyra reported less severe withdrawal symptoms when they abruptly stopped taking opioids, compared to those who were given dummy pills.
Use of lofexidine should be part of a long-term treatment plan for patients stopping opioids when physically dependent, the FDA and US WorldMeds indicated.
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.
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.
Lofexidine is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. To prevent such symptoms, doctors typically recommend slow withdrawal from the drug, the FDA said. "The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal", the FDA said.
Lucemyra's side effects could include low blood pressure, slowed heart rate, sleepiness and dizziness. Lucemyra was also associated with a few cases of syncope (fainting). When treatment is stopped, patients can experience a marked increase in blood pressure. Safety and efficacy in patients younger than 17 has not been established, the agency noted. The FDA has required another 15 studies to assess the drug's safety in situations not described in the current approval, including use in children and use that exceeds 14 days. Clinical studies will be required to evaluate the safety of Lucemyra in clinical situations where use could be expected to exceed the maximum 14-day treatment period for which the product is now approved, such as gradual opioid taper; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after lofexidine is stopped. They include both animal and human studies.
Lofexidine had fast-track designation and was reviewed under the FDA's priority review process. There are several drugs on the market that can be used to treat the overall disorder, but some of them are hard to access.