A Louisville company is hoping that its drug will help temper the impact of the opioid crisis that has gripped Kentucky and the nation.
The non-opioid medication, also known as lofexidine hydrochloride, could allow people take a crucial step toward getting off heroin or prescription opioids.
“We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction,” FDA Commissioner Scott Gottlieb said in a news release. “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.”
US WorldMeds anticipates that Lucemyra’s use will go beyond those who are full-fledged addicts.
“There are many people who are physically dependent, meaning if you stop it, you’re going to get withdrawal symptoms,” but those people may not be to the point of negative social behavior, such as stealing things or ruining relationships, said Dr. Mark Pirner, senior medical director of Clinical Research and Medical Affairs for US WorldMeds.
Because Lucemyra will be available without the restrictions surrounding drugs like buprenorphine or methadone, patients potentially will be able to get it from their family doctor, Pirner told Insider.
So people who have been afraid to seek help “might be willing to now go talk to their health care provider,” he said.
Lucemyra was licensed by US WorldMeds in the early 2000s, Pirner said.
US WorldMeds — a former Vogt Award winner in Louisville — “has been developing the data needed for FDA approval for over 10 years,” he said, adding, “Being a Louisville-based company is a main priority and one of the core mission visions of US WorldMeds.”
Lucemyra suppresses the neurochemical surge that leads to the sometimes agonizing symptoms of opioid withdrawal, such as pain, muscle twitching and stomach cramps. Even with Lucemyra, the process isn’t expected to be easy, Pirner said.
“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. ” … They’re not going to feel great, so they need to stay hydrated, they shouldn’t drive — common sense things.”
The drug, which will be available in pharmacies across the country in August, was approved 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, according to US WorldMeds.
“We are humbled to bring to the market the first and only non-opioid treatment for the mitigation of withdrawal symptoms — and are grateful for the urgency demonstrated by the FDA in rapidly reviewing and approving this important treatment,” US WorldMeds Chief Executive P. Breckinridge “Breck” Jones, said in a news release.
The FDA is requiring 15 postmarketing studies, including both animal and human studies.
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. Total treatment may last up to 14 days.
Potential side effects include low blood pressure, slow heart rate, dizziness, sleepiness, fainting and dry mouth. Also, the patient may be more sensitive to the effects of lower amounts of opioids, so they could overdose or die if they go back to using opioids to the extent that they did before they stopped using opioids.