The Food and Drug Administration approved of Lucemyra, a treatment for adults suffering from opioid withdrawal symptoms.
"As part of our commitment to support patients struggling with addiction, we're dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids", said FDA Commissioner Scott Gottlieb, M.D.
Patients usually manage withdrawal symptoms by switching the opioid with another medication, or by using therapy. "The lofexidine data demonstrate that, compared with placebo, study participants treated with LUCEMYRA experienced less severe withdrawal symptoms and were significantly more likely to complete opioid withdrawal treatment".
The studies evaluated benefit using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) to assess opioid withdrawal symptoms that included feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia. It is not approved as a treatment for opioid use disorder.
Opioids are synthetic painkillers generally prescribed by doctors or used in hospital emergency rooms.
Lucemyra is an oral treatment and can be used for only 14 days.
Opioid withdrawal includes symptoms - such as anxiety, agitation, sweating, vomiting, diarrhea and drug craving - that occur after stopping or reducing the use of opioids.
The FDA is requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct safety studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids.
Lucemyra is an orally available alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, a neurotransmitter that plays a key role in many opioid withdrawal symptoms.
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.
The FDA granted this application Priority Review and Fast Track designations, and an independent FDA advisory committee supported the approval of Lucemyra at a meeting held March.
Opioids were involved in more than 42,000 overdose deaths in 2016, the past year for which data was available, according to the U.S. Centers for Disease Control and Prevention.