profishingrods.com
profishingrods.com May 20, 2018


FDA approves first non-opioid drug for treating opioid withdrawal symptoms

17 May 2018, 11:42 | Randall Craig

FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

FDA approves Lucemyra to treat symptoms of opioid withdrawal and help patients overcome addiction

"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", Gottlieb said in a press release. Extra creature security studies will be required to help longer-term utilize, (for example, amid a progressive opioid decrease in torment patients stopping opioid analgesics) and use in youngsters.

US WorldMeds explained that Lucemyra "suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal".

The drug Lofexidine, marketed as Lucemyra, will be the first non-opioid treatment for managing withdrawal symptoms. Additionally, the therapy has not been approved to treat opioid use disorder, but is meant to be used as part of a long-term treatment plan for the condition. Lucemyra was approved to treat withdrawal symptoms for up to two weeks. Treatment may continue for up to 14 days and should be discontinued gradually over 2-4 days.

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.

Lucemyra, a selective alpha 2-adrenergic receptor agonist, works by reducing the release of norepinephrine and decreasing sympathetic tone; the actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal. To prevent such symptoms, doctors typically recommend slow withdrawal from the drug, the FDA said. The activities of norepinephrine in the autonomic sensory system are accepted to assume a part in a significant number of the side effects of opioid withdrawal. Some patients received Lucemyra, and some patients received a placebo. When treatment is stopped, patients can experience a marked increase in blood pressure.




The FDA said it would be requiring 15 postmarketing studies on lofexidine, "including both animal and human studies" to examine whether the drug could also be used in gradual opioid tapers and in pediatric patients, and also to better understand potential effects on blood pressure and hepatic function.

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.

The approval of WorldMed's Lucemyra was expedited in an effort to combat the opioid epidemic. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren't over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.

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.



Other News

Trending Now

Watch today's 'Call of Duty: Black Ops 4' reveal event here
Officially, nearly nothing has been said about the game, except that it's out on October 12 for Xbox One , PlayStation 4, and PC. In fact, this will be the fourteenth consecutive year with a new Call of Duty game, which is truly astounding.

YouTube just added songwriter, label and publisher credits to millions of songs
YouTube follows in Spotify's footsteps-the streaming service added credits back in February. The new section will show up on over half a billion videos.

Nintendo at E3 2018
Nintendo announced on Wednesday fans will need to reserve play slots to play Super Smash Bros. for Switch before June's show. Nintendo will also give out exclusive Nintendo Switch pins to random fans who bring their console with them to the show.

Royal Challengers Bangalore vs Sunrisers Hyderabad Live Cricket Score T20 Match Today
Williamson then combined with Manish Pandey as both the batsmen put on 135 run stand to take the team closer to win . Kohli and ace South African batsman AB De Villiers are RCB's key players as far as the batting in concerned.

Attempts to Regain Footing? Walmart Inc. (WMT)
It operates through three divisions: Walmart U.S., Walmart International, and SamÂ's Club.The P/E ratio is 25.77. Sessa Capital Im L.P. holds 0.69% of its portfolio in CompX International Inc. for 431,732 shares. (NYSE: WMT ).

Facebook's new features will come to India first
In another case linked to an online personality test misusing data of Facebook users, the data of a further 3 ... A company spokesperson said all these features should be available to US audiences in the near future.

New Jersey school bus and truck in head-on collision
Authorities confirmed multiple injuries to NBC, but did not detail how many or whether they included children. It happened around 9:30 a.m. with a bus carrying middle school students from the Paramus school district.

Reuben Foster's Ex-Girlfriend: Domestic Violence Claim 'A Money Scheme'
Shortly after the fight Foster attempted to end the relationship, and that's when Ennis went into panic mode. He has had a pretty tumultuous football career since leaving Tuscaloosa.

Children were on bus that crashed with truck
A school bus and a dump truck collided this morning on I-80 westbound in Morris County, N.J., according to authorities. Family members tell Eyewitness News the bus was headed to Waterloo Village as part of a field trip for fifth graders.

Ocado Teams Up With Kroger: What The Analysts Said
(KR), under which Kroger will use Ocado's technology in the US for grocery and other food-distribution activities. Shares in the group, which listed in 2010, jumped over 50 percent in early Thursday to trade at a record high.