Used for more than two decades in the United Kingdom, the oral drug isn't meant to treat opioid addiction or curb drug cravings.
Developed under private company US WorldMeds, Lucemyra works by diminishing the release of norepinephrine, a neurotransmitter that relays feelings of pain and affects withdrawal symptoms, research suggests.
The most common side effects from treatment with Lucemyra include hypotension (low blood pressure), bradycardia (slow heart rate), somnolence (sleepiness), sedation and dizziness. Safety and efficacy in patients younger than 17 has not been established, the agency noted.
The drug Lucemyra reduces the severity of withdrawal symptoms but can not eliminate them altogether.
Government agencies are trying to quickly usher new products to the market to address the need - but that hasn't panned out yet.
Privately held US WorldMeds said it had not yet set a price for Lucemyra. The FDA reviewed Lucemyra under Priority Review, which is granted to submissions for medications that would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. Announcing the move in a press statement yesterday (May 16), the agency noted that Lucemyra (lofexidine hydrochloride) is meant to help adults who abruptly stop taking the addictive painkillers, and is only approved for treatment for up to two weeks. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help.More news: PUBG Mobile update brings a new desert map and more
More news: USA fighters intercepted two Russian bombers off the coast of Alaska
More news: Hawaii's Kilauea volcano spews huge cloud of ash
Lucemyra suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal.
The FDA is requiring 15 postmarketing examines, including both creature and human examinations.
The newly approved drug isn't a medication for opioid addiction, but is seen as a step toward helping some people begin medication-assisted treatment, seen as the gold standard of addiction care.
New medication targets symptoms experienced when reducing or stopping opioids due to physical dependence. The FDA also points out that these symptoms can arise in patients who are taking opioid painkillers appropriately, as well as those with opioid use disorder.
The FDA approved Lucemyra, the first nonopioid treatment for adults managing opioid withdrawal symptoms, the agency announced May 16.
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".