The U.S. Food and Drug Administration declared on Jan. 9 that it has approved Egalet Corp's long-acting opioid painkiller called Arymo ER. The decision came after the recommendation of an independent panel of advisors, which voted for the approval of the drug, in August 2016. The vote was 18 to 1.
Additionally, the panel also recommended labeling the drug as an abuse-deterrent product for people who will try to dissolve and inject the medicine.
Egalet Corp's Arymo ER: FDA Approved
The FDA did not immediately publish a statement after the panel's recommendation of the abuse-deterrent label. The company's shares then dropped by 5 percent, as the FDA did not include any statement about the drug preventing abuse through inhaling and chewing. In publishing the approval, the FDA ran counter to the independent panel, whose suggestion back in August was to label the product as being an abuse-deterrent when administered via all the three possible routes: nasal, oral and intravenous.
According to the FDA's statement, another product made by Daiichi Sankyo, MorphaBond, has market exclusivity on claiming that it deters snorting, until Oct. 2, 2018, which made the Egalet's approval only half good news. The FDA did not go into any details about the oral claim requirements not having been met. However, starting October 2018, Egalet Corp will have a new chance at trying to incorporate the claim on its product label.
Arymo ER was approved in three separate dosage strengths of 15, 30 and 60 mg.
"Given the need for treatments for the millions of Americans living with chronic pain, the growing problem of prescription abuse and the fact that we know diversion is a huge problem, it is important that we have more abuse-deterrent treatment options, like ARYMO ER, if and when these pain treatments end up in the wrong hands," noted Nathaniel Katz, M.D., neurologist and pain specialist as well as founder and president of Analgesic Solutions in a news statement.
The FDA is not forced by law to follow the panel's decisions although most of the time it approves what the advisory committee votes.
The medicine is a long-acting variation of morphine, and its purpose is to treat severe pain, which requires daily opioid treatment with no interruptions. The medicine will, therefore, be used mostly for long-term administrations.
Fighting Opioid Overdose
The FDA's decision comes in the context of the alarming rates of opioid abuse, including heroin and prescription painkillers. The abuse has reached unprecedented rates in 2016, and it is now spread in epidemic proportions across the United States.
According to the Centers for Disease Control and Prevention, opioid overdose accounts for approximately 78 daily deaths in the United States, and the number of deaths caused by synthetic opioid overdose has increased by 72.2 percent in the span of one year.
"During 2010-2015, the rate of drug overdose deaths in the United States increased in 30 states and DC, remained stable in 19 states, and showed decreasing trends followed by increases in two states. From 2014 to 2015, drug overdose deaths increased by 5,349 (11.4%), signifying a continuing trend observed since 1999. Opioid death rates increased by 15.6% from 2014 to 2015," quotes the CDC report.
