FDA approves 1st nonopioid drug to ease withdrawal symptoms
- Author: Ismael Montgomery May 18, 2018,
May 18, 2018, 9:32
"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.
Data from the studies revealed that those treated with Lucemyra had less severe withdrawal symptoms and were significantly more likely to complete a seven-day opioid detoxification treatment compared to individuals in the group given placebo pills.
Lucemyra, an oral selective alpha 2-adrenergic receptor agonist, limits the body's output of norepinephrine, the hormone believed to play a role in symptoms of opioid withdrawal, the FDA said.
The NIH says these symptoms aren't directly life-threatening, but they can drive the patient back to opioid use - often overdosing after experiencing withdrawal. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help.
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Clinical studies will be required to evaluate the safety in situations where use could be expected to exceed the maximum 14-day treatment period for which Lucemyra is now approved; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after treatment is stopped.
"Lucemyra offers new hope to people who want to discontinue opioid use and are struggling with the agonizing symptoms of opioid withdrawal", said P. Breckinridge Jones, chief executive officer and founder of US WorldMeds.
Side effects of the treatment included low blood pressure, dizziness, sleepiness, slow heart rate, and a few cases of syncope (fainting). These include animal and in-human studies to examine long-term use of Lucemyra, potentially during a gradual opioid dose-reduction process rather than sudden removal. These symptoms of opioid withdrawal occur both in patients who have been using opioids appropriately as prescribed and in patients with OUD. The drug can also elevate the risk of abnormal heart rhythms.
New medication targets symptoms experienced when reducing or stopping opioids due to physical dependence. "The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal", the FDA said. Safety and efficacy in patients younger than 17 has not been established, the agency noted. Additionally, an independent FDA advisory committee supported the approval at a meeting in March.
The FDA is requiring 15 additional studies to further assess the drug's safety when used in children, for longer than 14 days, and in other situations that were not tested in the earlier trials. The approval for making the drug is granted to US WorldMeds LLC.