"It can't be dispensed to patients for home use and should not be used for more than 72 hours".
The drug, Dsuvia, is a quick-dissolve tablet designed as an alternative to the rapid-fire infusion of pain meds available via IV at a hospital. The objective, of course, was for the committee to determine the drug's overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide.
Kolodny called Dsuvia an "exceptionally dangerous" drug that is 10 times stronger than fentanyl, which is 50 times stronger than heroin.
The chair of an FDA advisory panel that considered whether the drug should be approved, Dr. Raeford Brown, called it a "danger to the general public health" last month.
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In a November 2 statement released by the consumer group Public Citizen, the chairman of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee criticized the decision, reiterating his opposition he had previously voiced last month in a letter to FDA leaders. That panel recommended the drug's approval despite his warning.
Along with the approval, Commissioner Scott Gottlieb released a statement of more than 2,200 words explaining the decision as well as how the agency will consider future opioid applicants. And in doing so, the agency addressed wider regulatory thinking for endorsing such a medicine amid nationwide angst about overdoses and deaths attributed to opioids. Alan says the concern around the drug is "valid given the potential for abuse". Dsuvia (sufentanil) will be marketed by California-based maker AcelRX. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.
"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 related to battlefield wounds". Company executives said they expect to launch Dsuvia in the first quarter of 2019.
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. It is the tablet version of an opioid that's now marketed for intravenous delivery, and was also approved in Europe just last July under the brand name Dzuveo.