FDA approves first non-opioid to treat withdrawal symptoms in adults

The FDA approved a nonopioid drug to assist with opioid withdrawal symptoms as a tool to fight the U.S. opioid crisis

FDA on Wednesday (May 16) approved US WorldMeds LLC's Lucemyra, the first agency-approved non-opioid treatment for mitigating the symptoms of opioid withdrawal.

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 agency noted that the treatment may not completely prevent withdrawal symptoms (eg, anxiety, agitation, sleep problems, muscle aches, sweating, nausea, diarrhea, drug craving), and is only approved for use up to 14 days.

"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.

Gottlieb said fear of withdrawal often discourages those with a physical dependence from seeking treatment, and the potentially intense symptoms often contribute to relapses.

Iranian president attempts to salvage nuclear deal after US' exit
The head of the elite Revolutionary Guards also warned against relying on foreign powers to guarantee Iran's interests. On Wednesday, Mr Jafari had cast doubt on European nations' ability to save the nuclear accord.

As a major aspect of the U.S. Bureau of Health and Human Services' Five-Point Strategy to Combat the Opioid Crisis, the FDA stays focused on tending to the national emergency of opioid compulsion on all fronts, with a critical spotlight on diminishing presentation to opioids and averting new enslavement; supporting the treatment of those with opioid utilize scatter; cultivating the advancement of novel torment treatment treatments and opioids more impervious to manhandle and abuse; and making a move against the individuals who add to the unlawful importation and offer of opioid items. It is not approved as a treatment for opioid use disorder.

Studies in pediatric patients will be conducted on newborns with neonatal opioid withdrawal and studies of various age groups of children with opioid withdrawal related to stopping medical-prescribed opioid drugs. Trial participants treated experienced less severe withdrawal symptoms compared to placebo and were significantly more likely to complete a seven-day opioid discontinuation treatment. Less common reactions could include fainting and abnormal heart rhythms. When Lucemyra is stopped, patients can experience a marked increase in blood pressure.

Patients with chronic pain can attend the FDA's "Patient-Focused Drug Development for Chronic Pain" meeting on July 9 from 10 a.m.to 4 p.m. Patients can attend in person in Maryland or through a webinar by registering online.

An independent FDA advisory committee supported approving Lucemyra in March. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Related news:

Hot News

isis-killer-beheading-video-story-top Margot Kidder, who found movie stardom in 'Superman,' dies at 69
May 16, 2018 - 09:28
It is not known yet what Kidder - who once dated directors Brian De Palma and Steven Spielberg - died from, according to TMZ . She was diagnosed with bipolar disorder and spoke out about it in an effort to remove the stigma of the disease.

isis-killer-beheading-video-story-top Meghan's sibling says their dad stressed out by press pack
May 16, 2018 - 09:21
Or self-proclaimed feminist Meghan could walk herself down the aisle , another non-traditional choice. The photos depicted Markle apparently preparing for his daughter's wedding this weekend.

isis-killer-beheading-video-story-top Hedman, Lightning beat Caps to cut East final deficit to 2-1
May 16, 2018 - 09:16
Lightning Head Coach Jon Cooper offered his perspective on home ice after the game: "Home ice advantage is Game Seven to me". The Lightning Captain wired a puck through and gave Tampa a 1-0 lead 13:53 into the game.

isis-killer-beheading-video-story-top Nick Read to head Vodafone
May 15, 2018 - 22:23
Vodafone Chief Executive Vittorio Colao delivers a keynote at the Mobile World Congress in Barcelona, Spain, February 26, 2018. Read has been CFO since April 2014 and was previously CEO for the Africa, Middle East and Asia Pacific region.

isis-killer-beheading-video-story-top NASA has fresh hope of finding signs of alien life
May 15, 2018 - 22:20
Back in 1997, it's nearly as if researchers didn't know to look for plumes of this sort - or simply did not expect such things. The potential existence of water captured the interest of scientists as it could mean the moon is able to support life.

isis-killer-beheading-video-story-top Commandos deployed in 3 key government compounds in Farah city
May 15, 2018 - 22:19
Reinforcements including commando units as well as the Afghan air force were battling Taliban fighters around the city, he said. Both the Taliban and Islamic State forces have staged shooting and suicide bombing attacks in Kabul and several other cities.

isis-killer-beheading-video-story-top Congo-Kinshasa: British Tourists Kidnapped in DR Congo Released After Two Days
May 14, 2018 - 05:49
We wish to extend our deepest condolences to her family and our sincerest gratitude for her bravery and service to Congo. Earlier, tributes were paid to 25-year-old Ms Baraka, the eighth ranger to be be murdered at the park this year.

isis-killer-beheading-video-story-top Thiem defeats Nadal in Madrid
May 13, 2018 - 01:08
The 24-year-old Austrian broke Anderson in a nine-minute opening game which was enough to secure the first set in 49 minutes. Dominic Thiem defeated Kevin Anderson in straight sets to reach the Madrid Open final for the second year in succession.

isis-killer-beheading-video-story-top Neymar to resume training on Sunday, says PSG
May 13, 2018 - 01:07
Media reported he now wants to move to Real Madrid , who tried to sign him in 2013 before the Brazilian opted for Barcelona . What's worrying us is what is going on at the moment. "The friendship that we had was something very attractive ".

isis-killer-beheading-video-story-top Fans go insane as Hamburg suffer first Bundesliga relegation
May 13, 2018 - 01:05
Schalke had already wrapped up second place, but it was between Dortmund, Leverkusen and Hoffenheim for the remaining two spots. The day started disastrously for Hamburg, as Joshua Guilavogui fired Wolfsburg ahead in the opening minute against Cologne.

isis-killer-beheading-video-story-top Leinster Looking For 4th European Title This Evening
May 13, 2018 - 01:03
"We looked at each other in the changing room after the Scarlets match and thought we could go to the next level". He was their goal kicker and their playmaker who got them going.

isis-killer-beheading-video-story-top GOP lawmaker calls on Trump to fire aide who mocked McCain's health
May 12, 2018 - 07:30
It ended with the White House embroiled in a controversy over a staffer named Kelly Sadler who joked in a staff meeting that Sen. John McCain , R-Ariz., had passed, sending out a a draft email to reporters with a subject line that read, "VFW Remembers Sen".

isis-killer-beheading-video-story-top Trudeau regrets Trump decision to pull out of Iran nuclear agreement
May 11, 2018 - 04:01
"It is clear to me we can not prevent an Iranian nuclear bomb under the decaying and rotten structure of the current agreement". Trump also announced plans to re-instate sanctions against Iran.

isis-killer-beheading-video-story-top Mueller Won't Allow Trump To Answer Interview Questions In Writing
May 11, 2018 - 03:59
Although Trump has hinted that such a move could be coming, the detainees have not yet been released as predicted by Giuliani. Of course his attorneys prefer that, because they know that when Trump starts talking, he starts lying.

isis-killer-beheading-video-story-top Three Labor MPs, Rebekha Sharkie resign to fight byelections
May 10, 2018 - 06:43
Sharkie is from the Centre Alliance, formerly the Nick Xenophon Team, the fortunes of which have collapsed. But opposition leader Bill Shorten said the High Court had set a new precedent on Wednesday.