A new drug approved by the FDA has attracted the attention of those at the forefront of the fight against the opioid epidemic.
Dsuvia, made by a 13-year-old Californian company, AcelRx Pharmaceuticals, is a potent opioid 50 to 100 times more potent than morphine and stronger than fentanyl.
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It's "very scary," said Alpharetta, Georgia, resident Dawn Camarda, who founded the Blake Meier New Life Foundation after her 26-year-old son died of an overdose of fentanyl in a motel room in West Palm Beach, Florida in 2016.
Before the drug was approved, she said, "If this drug comes through, I certainly hope that there are strict regulations. When this drug hits the street, it's even more devastating than fentanyl. I wish the drug companies were working on a non-addictive painkiller rather than a stronger opioid, as we all know that this new drug will be a big problem with the addiction. "
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The Advisory Committee on Anesthetics and Analgesics of the US Food and Drug Administration voted in favor of Dsuvia at 10-3 last month. The FDA gave final approval on Friday.
The fast-acting product contains a synthetic analgesic known as sufentanil and is intended to be taken in a supervised medical environment, such as an emergency room in a hospital. The new product is in tablet form, which dissolves quickly under the tongue.
Dr. Pamela Palmer, co-founder and Chief Medical Officer of AcelRx, defended the drug.
She fills a much-needed gap, she said.
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"It's not at all for prescription purposes and certainly not for the home," said Palmer.
The product is for moderate and severe pain.
"There is currently no way to treat your pain quickly without stinging you with a needle," Palmer said. "If you have broken your thigh bone and are obese or have elderly or blood thinners, this can be very painful and cause many bruises. If you take a pill, you have to swallow it with water and wait until it enters, which can take up to an hour. At the moment, everything is available. For the first time, we developed a small tablet that goes under the tongue and dissolves in about six minutes. "
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There are no painkillers currently available for patients who do not have cancer.
Dsuvia was made aware when a rare attempt by both parties began, with President Donald Trump recently signing a comprehensive law that improves access to treatment and research on non-addictive medicines that could be used to fight pain.
The fact that an even more powerful drug is approved is confusing to Farley Barge, co-founder of Navigate Recovery Gwinnett. He has seen several relatives and friends struggling with opioid and alcohol addiction.
"As with most opioid drugs, the potential for abuse is great," he said.
He is worried that the drug may still fall into the wrong hands, especially when there is demand.
"We know that one of the reasons people use drugs is that what a patient takes stops working over time," he said. "Their tolerance for opioids is increasing, so this drug is just another step in the process, and I'm wondering whose interests we're following."
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According to the Centers for Disease Control and Prevention, more than 63,000 people in the US died in 2016 from an opioid overdose. Although more than one drug was potentially involved in death, 66.4 percent of the cases involved prescription and / or illegal opioids.
"Several people we know said it was the worst thing they ever did if they followed their doctor's instructions, and in the end they were addicted to opioids," Barge said. "We keep doing the same thing and expect a different result. With FDA approval, these types of drugs are just beginning to increase. "
Palmer said AcelRx has taken steps to monitor the use and supply of the drug.
"I'm not saying that drugs delivered to hospitals are never stolen or misused, but that's a tiny fraction of the problem of the opioid epidemic," said Palmer.
Dr. But Gaylord Lopez, director of the Georgia Poison Center, is still worried.
"Of course you always have to blink twice, especially given the opioid epidemic, when you hear that a new product is coming on the market," he said. "It's another straw on the back of the camel. The problem is that the back of the camel is already broken. "