FDA Approval Has Immediate Addiction Concerns

Orange County, CA - November 7th, 2018 -   There are nearly 400 brand and generic name opioids on the market. Opioids are often used to treat chronic and acute pain. When used correctly, it can be an essential component of treatment. However, serious risks can be associated it painkillers, including misuse, opioid use disorder (addiction), overdoses, and death. According to the Centers for Disease Control and Prevention (CDC), from 1999 to 2016, more than 200,000 people in the United States died from overdoses related to prescription opioids.

Despite the ongoing opioid crisis in the United States, the Food and Drug Administration (FDA) has approved a new opioid tablet that is 1,000 times more potent than morphine and ten times stronger than fentanyl. Dsuvia, made by AcelRx Pharmaceuticals Inc., is a tablet in a single-dose that is administered under the tongue by health care professionals, to patients in hospitals, surgical centers, and emergency rooms as a fast-acting alternative to IV painkillers.

AcelRx will market the drug beginning in early 2019 at a wholesale price of $50 to $60 per dose; the company is not providing information on expected sales. The drug is intended for use within health-care settings and perhaps on the battlefield. It would not be available in retail pharmacies. “The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain,” said FDA Commissioner Dr. Scott Gottlieb.

However, critics were quick to disapprove, with saying Dsuvia will be diverted to improper use, and cause more opioid overdose deaths. “It is certain that Dsuvia will worsen the opioid epidemic, and kill people needlessly. It will be taken by medical personnel and others for whom it has not been prescribed, and many of those will overdose and die,” said Sidney Wolfe, founder of Public Citizen’s Health Research Group, in a statement.

FDA Approval Has Immediate Addiction Concerns

The drugs inside medical facilities are always secured; the FDA says the most significant risk of diversion is among medical personnel themselves. According to a 2016 survey organized by the Substance Abuse and Mental Health Services Administration (SAMHSA) narcotics are rarely stolen from hospitals, doctors’ offices, or pharmacies. Less than 1 percent said they attained opioids that way.

One aspect that weighed heavily in the Dsuvia decision is military interest in the drug. The military wants to explore whether the painkiller can be used on the battlefield rather than the inconvenience of liquid analgesics. Public documents show the Pentagon has spent millions of dollars helping to fund AcelRx’s research. “The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain,” said Scott Gottlieb.

Dsuvia cannot be taken for more than 72 hours; it will have the same black-box warnings as are necessary for all opioids, which gives information about the risk of misuse and abuse that can lead to addiction and death. It has been about 15 years of research to improve the standard of care for managing acute pain in medically supervised settings.

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Ampronix is a renowned authorized master distributor of the medical industry's top brands as well as a world-class manufacturer of innovative technology. Since 1982, Ampronix has been dedicated to meeting the growing needs of the medical community with its extensive product knowledge, outstanding service, and state-of-the-art repair facility. Ampronix prides itself on its ability to offer tailored, one-stop solutions at a faster and more cost-effective rate than other manufacturers.

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FDA Approval Has Immediate Addiction Concerns Orange County, CA – November 7th, 2018 –   There are nearly 400 brand and generic name opioids on the market. Opioids are often used to treat chronic and acute pain. When used correctly, it can be an essential component of treatment. However, serious risks can be associated it painkillers, including […]