FDA approves the use of injectable opiates to help fight the drug crisis in the United States – tech2.org

FDA approves the use of injectable opiates to help fight the drug crisis in the United States



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In an effort to combat the opioid crisis in the United States, the United States Food and Drug Administration approved a new form of medication that helps patients alleviate their withdrawal symptoms.

The drug called buprenorphine was previously approved fifteen years ago. A long time ago, in the form of a daily tablet that dissolves under the tongue and then in 2016, the agency approved an implant. Thursday's FDA announcement involves the same drug; however, patients will now be able to receive it once a month as an injectable.

"It's potentially a game changer," Dr. Andrew Kolodny, co-director of opiate policy research at Brandeis University, told STAT. "This could become the first line [medication] for opioid addiction, it could open up opportunities to get more patients with buprenorphine."

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] Individual, a pharmaceutical group based in London, are the creators of the new injectable product approval called Sublocade. In an FDA voting session, an overwhelming majority of the committee (18-1) supported the approval of Sublocade, Reuters reports.

"As part of our ongoing work to support the treatment of those suffering from opioid addiction, the FDA plans to issue a guide to expedite the development of new addiction treatment options," the commissioner said in a statement. of the FDA, Dr. Scott Gottlieb. "We will continue to seek efforts to promote a more widespread use of existing, safe and effective therapies approved by the FDA to treat addiction."

 12_1_ narcotic name In this illustration of the photograph, a bottle of the generic prescription pain medication Buprenorphine is seen at a pharmacy on February 4, 2014 in Boca Raton, Florida. The narcotic is used as an alternative to methadone to help addicts recover from heroin use. Joe Raedle / Getty Images

The approval of the drug occurs after two clinical trials of more than 800 adults with moderate opioid use disorder were conducted to severe. The results of the investigation revealed that those injected with Sublocade approved more urine tests and self-reported less opioid use over a six-month period, compared to the placebo group, the FDA says.

Once available, those who choose The new treatment can only be injected into a healthcare setting, reports CNBC. Like other FDA-approved addiction medications, Sublocade is not designed to be used as the sole treatment option, but rather as part of a more intensive program that includes counseling and psychosocial support. This type of combination treatment, known as drug-badisted therapy, is "one of the main pillars of the federal response to the opiate epidemic," the FDA announced in September.

Americans are dying of opioids at an alarming rate, so it is vital to find new ways to combat the opiate epidemic. In 2016, more than 64,000 people in the US UU They died from drug overdoses, including illicit drugs and prescription opioids, according to data from the National Institute on Drug Abuse.

"Given the magnitude of the opiate crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people lead a life of sobriety," said Gottlieb

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