Health Care

FDA Approves First Non-Opioid Treatment to Manage Withdrawal

FDA Approves First Non-Opioid Treatment to Manage Withdrawal

The FDA approved the first non-opioid medication to treat opioid withdrawal in adults, in order to "facilitate abrupt discontinuation of opioids in adults", the agency said Wednesday.

Lofexidine is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine.

Lucemyra (lofexidine hydrochloride) was originally meant to be a hypertension drug. When the norepinephrine release is reduced the symptoms may be eased.

Patients who go off opioid painkillers face excruciating withdrawal symptoms such as anxiety, nausea, vomiting, insomnia, muscle aches and more.

In patients using opioid analgesics appropriately as prescribed, opioid withdrawal is typically managed by slow taper of the medication, which is meant to avoid or lessen the effects of withdrawal while allowing the body to adapt to not having the opioid.

Cleveland Browns to be featured on HBO's 'Hard Knocks' this preseason
General manager John Dorsey overhauled the Cleveland roster in the offseason and isn't bashful about his expectations for the team.

Gottlieb said the FDA wants to "strike the right balance" between making policies that give patients who need opioids the proper accessibility and preventing opioid exposures that lead to new addictions.

The most widely recognized symptoms from treatment with Lucemyra incorporate hypotension (low circulatory strain), bradycardia (moderate heart rate), drowsiness (lethargy), sedation and wooziness. The investigations assessed advantage utilizing the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), which is a patient-detailed result instrument that surveys opioid withdrawal side effects. And those who seek assistance may relapse due to continued 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. Compared to the placebo group, patients treated with Lucemyra reported a lower severity of symptoms. There were a few cases of fainting or syncope and an increased risk of heart arrhythmias. More data is also needed to determine Lucemyra's safety and efficacy profile in patients younger than 17 years of age.

The FDA is requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct more studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them.

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. An advisory committee this March had approved Lucemyra and had advised the FDA accordingly.


  • Astronomers have found the oldest oxygen in the Universe

    Astronomers have found the oldest oxygen in the Universe

    For MACS1149-JD1 to contain substantial amounts of oxygen, many stars must have already gone through that whole life cycle. Ellis added, "But we have a clever trick that tells us how old the stars are already at that time in this galaxy".
    Five found dead at Denton County residence

    Five found dead at Denton County residence

    She says she's "extremely mad" at the judge who handled her divorce from Justin Painter of Fort Worth, the suspected shooter. The shooting is still under investigating by the Denton County Sheriff's Office, Ponder police and The Texas Rangers.
    How To Play Super Smash Bros. Switch At E3 2018

    How To Play Super Smash Bros. Switch At E3 2018

    As always, people can keep an eye on https://e3.nintendo.com for all of Nintendo's latest updates from E3 2018 . For more details, be sure to read the FAQ below and check back as additional details will be added.
  • Man, Late To Board Flight, Tries To Yank Open Plane Door

    Man, Late To Board Flight, Tries To Yank Open Plane Door

    In a statement to news.com.au, Australian Federal Police confirmed it had responded to an incident at Terminal 4 this morning. A man has been charged with assault whilst trying to force his way on to a Jetstar fight at Melbourne airport yesterday.
    Fortnite Solo Showdown: What Is The New Limited Time Mode?

    Fortnite Solo Showdown: What Is The New Limited Time Mode?

    Finishing first in a match will earn you a full 100 point, which drops all the way down to just 25 points for places 76 to 100. Placements in this limited time mode will be specially tracked and determine rewards you receive at the end of the event.
    Batwoman And Gotham Are Coming To The Arrowverse!

    Batwoman And Gotham Are Coming To The Arrowverse!

    But Gotham City's existence was confirmed this season on Arrow when Oliver Queen made reference to the city, and to Bruce Wayne. Batwoman was first introduced into the pages of DC Comics back in 1956, before Kate Kane took on the mantle in 2006.
  • Women's T20 Challenge to be played in Mumbai on May 22

    Women's T20 Challenge to be played in Mumbai on May 22

    The BCCI has chose to make a match on the lines of the IPL for the women right before the IPL's current season. In this regard, the IPL Chairman Rajiv Shukla said in his statement: "The IPL will continue to be as usual".
    Autograph Seeker Sues Cardi B and Offset Over Met Gala Beatdown

    Autograph Seeker Sues Cardi B and Offset Over Met Gala Beatdown

    According to The Wrap, Arnold claims in his suit that Cardi and Offset "ordered the beatdown after verbally threatening him". Migos rapper Offset was last night in Atlanta after getting into a pretty bad vehicle accident.
    The Red Hydrogen One will debut on Verizon and AT&T

    The Red Hydrogen One will debut on Verizon and AT&T

    They will be previewing the phone to the public showing games, movies, and other content that will be available on it. Another detail missing from the carriers' announcements is how much you can expect to pay for the Hydrogen One.
  • Report that Obama FBI spied on campaign could be 'bigger than Watergate'

    Report that Obama FBI spied on campaign could be 'bigger than Watergate'

    "Wow, word seems to be coming out that the Obama FBI SPIED ON THE TRUMP CAMPAIGN WITH AN EMBEDDED INFORMANT, '" Trump tweeted.
    Mac Miller Arrested For DUI & Hit and Run in California

    Mac Miller Arrested For DUI & Hit and Run in California

    Just one week ago, superstar singer Ariana Grande revealed she and Miller had amicably split two years into their relationship. When cops arrived at the crash site, they were able to run Miller's plates and find out the address listed on his registration.
    Trump's Surgeon General Jumps Into Action In Medical Emergency On Delta Flight

    Trump's Surgeon General Jumps Into Action In Medical Emergency On Delta Flight

    However, Adams said that it was a part of his duty and he was glad to assist the passenger. It's unclear what medical issue the passenger was suffering from.