Potentially Non-Addictive Morphine Pill Approved by the FDA
King Pharmaceuticals Inc. won the FDA’s approval to sell a safer painkiller—one that may be extremely difficult to abuse. The extended-release morphine product, Embeda, contains a chemical designed to counteract the morphine if the capsule is crushed, chewed, or dissolved in alcohol to get the full dose at once. This suggests that users trying to get high off the drug will have a hard time doing so.
Bloomberg’s Catherine Larkin reports that Embeda contains naltrexone, an antagonist used to help wean addicts off of opioid painkillers. If taken as directed, naltrexone passes through the system without any effect. But if the capsules are crushed or chewed, the naltrexone is released to counteract the sense of euphoria from the morphine.
However, King and the FDA noted that the evidence wasn’t conclusive that the naltrexone interferes with the morphine high. The prescribing information and medication guide will include data about two studies that show no evidence that the naltrexone reduces euphoria when Embeda is crushed or chewed, said Karen Riley, and FDA spokeswoman.
A boxed warning, the agency’s strictest, will be part of the prescribing information. The warning notes that drug is not to be crushed, dissolved or chewed and misuse can produce a potentially fatal overdose, Riley said.
In light of the recent increase in prescription drug abuse, King moves in front of at least five companies that have been racing to develop new painkillers with less addictive properties. The approval also justifies King’s acquisition of Alpharma, which developed Embeda and submitted it to the FDA on June 30, 2008.
“We’ve been waiting for this approval for several months - - it’s very exciting,” said Gary Nachman, an analyst at Leerink Swann & Co. in New York. “It is the key catalyst for King’s stock that investors have been focused on. The FDA’s approval helps validate the whole abuse deterrent category, and King has other products in this area behind Embeda that it’s working on.”
King is still awaiting an FDA decision on Remoxy, a tamper-resistant pill to compete with OxyContin, and Acurox, a short-acting oxycodone pill that prevents overdose. OxyContin has been increasingly abused by teenagers and others, and has led to several overdose deaths. As a result, regulators have urged companies to develop tamper-resistant alternatives.
Almost 5 percent of high school seniors say they have used OxyContin, according to the National Institute on Drug Abuse’s 2008 Monitoring the Future Survey. About 5.2 million Americans ages 12 and older misuse prescription painkillers, according to the latest National Survey on Drug Use and Health.
