FDA approves drug to help with opioid withdrawal symptoms

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

The Food and Drug Administration gave a green light to the first non-opioid drug aimed at controlling the withdrawal symptoms associated with opioid use.

For those addicted to opioids, quitting cold turkey can be a harrowing experience.

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. Thus far, patients with OUD have managed withdrawal by.

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

Gottlieb also said the FDA will be developing guidance documents for the most efficient path for developing drugs that can be used to treat various types of pain. It reduces the release of norepinephrine, a hormone believed to play a key role in triggering withdrawal symptoms. 866 adults participated in the study. Compared to the placebo group, patients treated with Lucemyra reported a lower severity of symptoms.

The drug Lucemyra reduces the severity of withdrawal symptoms but can not eliminate them altogether. The agency added that it's requiring 15 additional studies in both people and animals to evaluate factors such as longer-term use and the drug's effects on the liver. 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. Other treatments may also be prescribed by a patient's health care provider.

Baylor Men's Golf Cruises into Final Round at Six-Under
No. 27 UNF is now third at 5-under, while No. 33 Pepperdine is second at 7-under and No. 3-ranked Oklahoma is first at 9-under. Sharp opened the day with par to complete his second round 3-under-par 68, which was his second lowest score of the season.

OxyContin maker faces more lawsuits
Stenehjem says Purdue "misrepresented and trivialized" the risk of addiction from prolonged opioid use. In 2012, Purdue's OxyContin represented about 30 percent of the overall painkiller market.

Philippines chief justice, Duterte's critic, expelled by Supreme Court colleagues
The Congress, controlled by Duterte's allies, was due to vote on an impeachment complaint against Sereno next week. Sereno has the integrity to qualify her to hold the highest position in the Judiciary", De Castro said.

"Which is why patients may often not be able to go through the process without being an inpatient".

The FDA approves privately held US WorldMeds LLC's Lucemyra (lofexidine hydrochloride) for the management of opioid withdrawal symptoms in adults who abruptly discontinue opioids. Common side effects include a slow heart rate, low blood pressure, and sleepiness.

The safety and efficacy have not been established in children or adolescents 17 years of age and younger.

"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.

As part of a strategy to fight the crisis, the FDA said it's working to decrease opioid exposure to prevent new addictions and punish those who contribute to illicit opioid distribution.

Related news:

Hot News

isis-killer-beheading-video-story-top Golfer's wife arrested for drunken attack after missed cut
May 17, 2018 - 01:27
She later hangs up the phone, but when the 911 dispatcher calls the number back, her husband Lucas Glover answered the phone. Once they were able to get her into the backseat, she proceeded to kick the hell out of the door.

isis-killer-beheading-video-story-top EPA chief to face fresh questions about spending in senate hearing
May 17, 2018 - 01:25
Udall issued some of the harshest criticism of Pruitt, calling his leadership at the EPA "a betrayal of the American people". Udall tells Pruitt he's treating his position of public trust "as a golden ticket for extravagant travel and fine dining".

isis-killer-beheading-video-story-top Haspel Wins Backing of Senate Panel for CIA Post
May 17, 2018 - 01:25
But in her hearing, Haspel reminded lawmakers of the important role played by the intelligence community after the 9/11 attacks. As Director of the CIA , Gina Haspel will be the first operations officer in more than five decades to lead the Agency.

isis-killer-beheading-video-story-top Teacher 'Suspended For Relationship With Teen' Shot Dead Outside Mum's House
May 17, 2018 - 01:25
Reports say that the police report remained confidential until October, when the informant sent the email to DelTondo's school. Police are working to retrieve information from a cell phone after a woman was gunned down in her driveway in Aliquippa.

isis-killer-beheading-video-story-top North Korea has begun dismantling nuclear test site
May 17, 2018 - 01:24
The researchers published an analysis of satellite images from May 7th of the nuclear facility on Monday. A photo of the west portal shows that nearby buildings have also been demolished.

isis-killer-beheading-video-story-top US Senate approves bill in bid to retain net neutrality
May 17, 2018 - 01:23
But, he cautioned, it remains unclear how many voters will actually be motivated by net neutrality to go to the polls . Edward Markey (D-Mass.) - enables Congress to overturn agency actions within a certain timeframe and by majority vote.

isis-killer-beheading-video-story-top Ramadan 2018 to begin on Thursday, moon sighted in India
May 17, 2018 - 01:22
Opposition Leader Kamla Persad-Bissessar urged for Muslims to practice spiritual reflection as the season of Ramadan begins. The final 10 nights of Ramadan include intense prayer and are followed by a three-day holiday called Eid al-Fitr.

isis-killer-beheading-video-story-top Deputy who failed to confront Parkland school shooter getting $8k monthly pension
May 17, 2018 - 01:22
Peterson was thrown under the bus by Sheriff Scott Israel , who said at the time that the deputy should have "went in". If FDLE has found that anyone has broken any laws, they will be held fully accountable.

isis-killer-beheading-video-story-top Starbucks slams Seattle's new big business tax
May 16, 2018 - 07:54
That task force recommended $75 million through a tax on employers. "We took a huge step a year ago ", said Meg Olberding of HSD. While most the most dramatic moments in this saga unfolded over the last couple weeks, today's moment was months in the making.

isis-killer-beheading-video-story-top Boss Pep Guardiola: City will look to come back stronger next year
May 16, 2018 - 07:53
The atmosphere was unbelievable and I'm always happy to feel that I'm helping the team to win games and points - always happy about that".

Late-Night Hosts Tee Off on Opening of US Embassy in Jerusalem
May 16, 2018 - 07:48
John McCain's 2008 presidential campaign, called Kushner and Ivanka's role in the embassy unveil "outlandish". Congress passed the Jerusalem Embassy Act back in 1995, during Bill Clinton's presidency.

isis-killer-beheading-video-story-top Is Jupiter's moon Europa venting plumes of water vapor?
May 15, 2018 - 22:19
The spacecraft will make repeated flybys of Jupiter and more than 40 close passes by Europa at altitudes as low as 16 miles. This would let the scientists search molecules, which could be capable of supporting the formation of life there.

isis-killer-beheading-video-story-top Vodafone sees turnaround as profits for 2018 hit £2.5bn
May 15, 2018 - 22:19
Vodafone Chief Executive Vittorio Colao delivers a keynote at the Mobile World Congress in Barcelona, Spain, February 26, 2018. This has led to a mixed full year to 31 March 2018 operating performance, although one that looks pretty decent overall.

isis-killer-beheading-video-story-top Iran official says Europe has 60 days to give nuclear 'guarantees'
May 15, 2018 - 22:18
Yet Trump claimed Iran is on the cusp of threatening the United States with nuclear-armed ballistic missiles. The US action will also put the opening up of American Embassy on May 14 in Jerusalem in a different light.

isis-killer-beheading-video-story-top Taliban battle into west Afghan city in new crisis for government
May 15, 2018 - 22:17
The Taliban are stepping up their spring offensive , in an apparent rejection of a peace talks overture from the government. The Taliban urged the Afghan nation to boycott the elections and said that the country was "occupied" by foreign forces.