FDA OKs first non-opioid treatment for opioid withdrawal
17 May, 2018, 09:40 | Author: Earnest Bishop
On May 16, the Food and Drug Administration (FDA) approved of the first non-opioid treatment for adults suffering from opioid withdrawal symptoms.
"As part of our commitment to support patients struggling with addiction, we're dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids", said FDA Commissioner Scott Gottlieb, M.D.
Although researchers are confident that Lucemyra will help some patients manage symptoms, there are some concerns. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. And those who seek assistance may relapse due to continued withdrawal symptoms. "The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that's sometimes associated with the use of medication-assisted treatments". Such signs and responses are expected to occur in varying degrees, both in patients who used opioids correctly and in patients with OUD. It is not approved as a treatment for opioid use disorder. Scientists believe that this chemical greatly attributes to the majority of opioid withdrawal symptoms. The safety and efficacy of Lucemyra was supported by two randomized, double-blind, placebo-controlled clinical trials of 866 adults meeting Diagnostic and Statistical Manual-IV criteria for opioid dependence who were physically dependent on opioids and undergoing abrupt opioid discontinuation. These symptoms include feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia/problems sleeping. "The lofexidine data demonstrate that, compared with placebo, study participants treated with LUCEMYRA experienced less severe withdrawal symptoms and were significantly more likely to complete opioid withdrawal treatment". Common side effects include a slow heart rate, low blood pressure, and sleepiness. Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms. Some patients received Lucemyra, and some patients received a placebo. More studies are being planned to understand the safety and efficacy of Lucemyra in children or adolescents under 17 years of age.
"Most opiate overdose deaths occur in people who have just detoxed".
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.
The FDA said that Lucemyra is only approved for up to 14 days.
These come on within hours of a drug-dependent person stopping or cutting their dosage of opioids - whether it's prescribed or sought out for abuse.
The application was granted priority review and fast track designations, and an independent FDA advisory committee supported the approval of Lucemyra at a meeting held in March.
Opioids were involved in more than 42,000 overdose deaths in 2016, the a year ago for which data was available, according to the U.S. Centers for Disease Control and Prevention. There are several drugs on the market that can be used to treat the overall disorder, but some of them are hard to access.
The new OnePlus 6's dual camera system features a 16-megapixel main camera and a 20-megapixel secondary camera. The OnePlus 5 and the OnePlus 5T is getting Open Beta 10 and open Beta 8 update respectively.
There will also be cashback of Rs. 2,000, dedicated device insurance, and up to 370GB complimentary data from Idea as well. Further, customers will also be eligible to avail no cost EMI options for up to three months through all popular banks.
Raybould defeated three Democratic challengers in Tuesday's primary race for the seat held by Republican Sen. Lincoln City Councilwoman Jane Raybould won the Democratic primary to try and unseat Republican Sen.
La ceremonia, que comenzará este domingo a las 19:00 hora GMT, se celebrará en el pabellón de Armenonville, en el oeste de París. Emery ha ganado con el club parisino los cuatro torneos disputados en Francia: Liga, Copa, Copa de la Liga y Supercopa.
The restaurant operator reported $0.56 EPS for the quarter, missing the Thomson Reuters' consensus estimate of $0.68 by ($0.12). Finally, Elkfork Partners LLC purchased a new stake in The Cheesecake Factory during the fourth quarter worth about $267,000.
El crack decidió entonces operarse en Brasil , poniéndole un final prematuro a su polémica primera temporada en el PSG . Ni Dios agradó a todos, así que imagínate yo ", comentó sobre la presión mediática.
Eni Aluko to leave Chelsea
Chelsea Ladies secured the Women's Super League title and a domestic double by beating Bristol City Women 2-0 on Tuesday. The victory meant Chelsea added the league silverware to the Women's FA Cup they won against Arsenal at Wembley on May 5.
Microsoft to launch low-priced Surface
The cheapest version sounds like it will start at $400 without a keyboard cover or stylus, and with 64GB of internal storage. Intel is slated to provide the main processor and graphics for these devices that are said to be running Windows 10 Pro.