FDA OKs first non-opioid treatment for opioid withdrawal

17 May, 2018, 09:40 | Author: Earnest Bishop
  • FDA approves 1st non-opioid drug to ease withdrawal symptoms

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: Se resolvió el misterio del polémico audio — Yanny o Laurel
More news: How to watch the Preakness post position draw
More news: Whitney Houston Documentary Trailer Features Bobby Brown, Cissy Houston, & More

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

SEC Educates Investors by Launching Fake Crypto Site
The HoweyCoins site even comes sprinkled with a group of employees and celebrity promoters. But please don't expect the SEC to fly you anywhere exotic-because the offer isn't real.

Meghan's father will NOT attend the royal wedding... he's having surgery tomorrow
Staging the photos was meant to counter the way he had been "so unfairly presented in the media as being sort of shabby". He reportedly told the celebrity website TMZ that he doesn't want to embarrass the royal family or his daughter.

Teo no merece mi saludo, le faltó el respeto a Boca
El 'Apache' aseguró que el colombiano no merecía ser saludado por irrespetuoso. " Todos me conocen, saben que no soy falso ". Le faltó el respeto a la gente de Boca y a nosotros como colegas.

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.

Rapper TI 'wrongfully' arrested after losing key - lawyer
He spent 11 months in federal prison the following year for a probation violation after an arrest on drug charges. Atlanta-based rapper T.I. was arrested early Wednesday morning outside of the gated community where he lives.

'No me interesa ser el mejor de la historia': Messi
El crack rosarino abordó diferentes temas en una extensa entrevista de la TV nacional, a menos de un mes para el arranque de Rusia 2018.

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.

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.

Fianza de casi 500 mil dólares a madre de niños torturados
Las autoridades de Califronia, en Estados Unidos , detuvieron a una pareja bajo los cargos de abuso de menores . Ante medios locales ha dicho que se siente juzgada por tener tantos hijos y por darles educación en casa .

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.