FDA OKs first non-opioid treatment for opioid withdrawal

17 May, 2018, 09:40 | Author: Earnest Bishop
  • The FDA approved a nonopioid drug to assist with opioid withdrawal symptoms as a tool to fight the U.S. opioid crisis

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.

More news: Rapper TI 'wrongfully' arrested after losing key - lawyer
More news: Villa hold off Boro to reach Championship playoff final
More news: Neymar fue distinguido como el mejor jugador del año

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.

Recomendado:



Popular

Se resolvió el misterio del polémico audio — Yanny o Laurel
Las bocinas de baja calidad no son excelentes para producir graves y agudos de calidad. Este tuit dice "podés escuchar los dos cuando ajustás los niveles de bajos".

El Gobierno convocará a un "gran acuerdo nacional" para reducir el déficit
Manifestó que el rol de la entidad financiera es clave para superar las "turbulencias". Es más su interlocución directa con el Presidente es vista con recelo .

Michigan State compensará a víctimas de Larry Nassar con $500 millones
La Universidad Estatal de Michigan fue acusada de ignorar o desestimar las quejas sobre Nassar, algunas ya en la década de 1990. Las campeonas olímpicas de gimnasia Jordyn Wieber, Aly Raisman , Gabby Douglas y McKayla Maroney son algunas de sus víctimas.

How to watch the Preakness post position draw
Jerry Izenberg of NJ.com wonders if the horse and trainer Chad Brown have a shot to spring the upset at the Preakness . He earned his first win at the 2017 Breeders' Cup Juvenile and was the victor of this year's Bluegrass Stakes.

Rodolfo Cota dice adiós a Chivas y llega al León
La directiva rojiblanca negoció su venta definitiva con Grupo Pachuca , pero nunca llegaron a un acuerdo en el rubro económico. El Rebaño despidió a Cota a través de las redes sociales.

Bumble Bee CEO Indicted On Canned Tuna Price Fixing Charge
Lischewski is the fourth executive of San Diego-based Bumble Bee to be charged in the conspiracy. When the facts are known and the truth emerges, Mr.

Watch the OnePlus 6 event live stream right here starting at 12PM
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.

Rep. Don Bacon awaits challenge from Democratic opponent
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.

Tencent Revenue Growth Strong, But Adjusted Earnings Miss
The operating profit surged 59 percent to CNY 30.692 billion while the net profit going 61 percent higher to CNY 23.290 billion. Tencent had warned in March that heavy spending could crimp profit, sending shares sharply lower.

EE UU mantiene preparativos para cumbre entre Trump y Kim
Las declaraciones de Kim llegan después de que se pusieran en marcha, el 11 de mayo, los ejercicios militares conjuntos de EEUU y la República de Corea , llamados "2018 Max Thunder".