USFDA chief: First-ever withdrawal drug could vault more patients into addiction therapy
Patients
who go off opioid painkillers face excruciating withdrawal symptoms such as
anxiety, nausea, vomiting, insomnia, muscle aches and more. Now, thanks to an
FDA approval for US WorldMeds' Lucemyra, they'll have the first drug designed
to fight those symptoms.
Lucemyra won
its FDA nod on Wednesday based on two trials showing that the drug reduced
severe withdrawal symptoms better than placebo. Plus, more patients in the
Lucemyra arm completed a seven-day opioid discontinuation treatment.
Used for more than
two decades in the U.K., the oral drug isn't meant to treat opioid
addiction or curb drug cravings. But it can be used as part of a long-term
plan for quitting the powerful painkillers and staying opioid-free
long-term, the FDA said.
For
instance, Lucemyra could be a springboard into a
long-term medication-assisted addiction therapy such as Vivitrol
(naltrexone), an Alkermes drug that blocks the effects of opioids on the
brain—meaning one can’t feel the intoxication. Lucemyra works by reducing the
release of norepinephrine, a chemical in the body believed to play a part in
withdrawal symptoms.
“We know
that the physical symptoms of opioid withdrawal can be one of the biggest
barriers for patients seeking help and ultimately overcoming addiction,” said FDA
Commissioner Scott Gottlieb, M.D., in a statement. “The fear of experiencing
withdrawal symptoms often prevents those suffering from opioid addiction from
seeking help. And those who seek assistance may relapse due to continued
withdrawal symptoms.”
For patients
using opioids appropriately, withdrawal is usually managed by slow reduction in
doses. Patients abusing the drugs can suffer more severe withdrawal symptoms,
and those who intend to take Vivitrol or another addiction drug need
to withdraw from opioids first.
Because
Lucemyra can make withdrawal process easier for patients, National Institute on
Drug Abuse Director Nora Volkow, M.D., argues it could boost wider
use of Vivitrol, which differentiates itself from methadone and buprenorphine,
two other addiction treatments that belong to the opioid family.
“Lofexidine
could benefit the thousands of Americans seeking medical help for their opioid
addiction, by helping them stick to their detoxification or treatment regimens,” Volkow
said in her blog.
The FDA granted
Lucemyra the go-ahead after previous priority review and fast track
designations, and it comes after an independent scientific panel voted 11-1 in
favor of its approval.
The agency is
now requiring 15 postmarketing studies. 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. Lucemyra is currently
only approved for no more than 14 days of treatment. Studies will also take
place in pediatric patients, including on newborns with neonatal opioid
withdrawal and on different age groups of children.
Kentucky-based
US WorldMeds expects to launch Lucemyra in the U.S. in August.
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