Medical

Opioid 500 times stronger than morphine gets OK

Opioid 500 times stronger than morphine gets OK

In a highly controversial move, the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a "danger" to public health.

Dsuvia is 10 times more powerful than fentanyl.

Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis. The pill is placed under the tongue for quick absorption and has the same impact as five milligrams of intravenous morphine, reported The Washington Post.

Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths.

In a statement, he said, "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".

Although the FDA is committed to reducing the opioid crisis and despite their claims to work in the interest of addiction-free drugs, the latest opioid may go against everything that has been said. On Friday, new statistics released by the U.S. Drug Enforcement Administration found the number of opioid overdose deaths in the United States reached a new record previous year with 72,000 deaths - about 200 per day.

Another criticism to be voiced is that Dsuvia is unnecessary: a drug that will not really add any benefit to an already saturated-and very unstable-opioid market.




According to a prepared statement from AcelRx, in a randomized, double-blind, placebo-controlled clinical study, which enrolled 161 patients, ages 18 to 69 years, the medication demonstrated a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared to placebo. It would not be available in retail pharmacies.

US regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals.

The drug is intended for use within health-care settings and perhaps on the battlefield. The guidelines would allow the agency to consider a narcotic's benefit to public health, its risk of being diverted for inappropriate use or abuse and its unique benefits to groups of people in pain before deciding to approve an opioid.

More: Drugs kill more Americans than guns, cars and AIDS. The drug's manufacturer, AcelRx, said the drug will be marketed with the name Dsuvia and cost between $50 and $60 per dose. Most of that was the result of a record number of opioid-related deaths.

Furthermore, others also noted that the drug could be easily diverted by medical personnel, despite risk mitigation plans, and with the restriction that it could only be used in certified medically supervised healthcare settings.

Including brand name and generic drugs, there are almost 400 opioids now on the market.