FDA Panel: Embeda Appears Less Susceptible to AbuseAccording to an FDA advisory panel, Alpharma Inc.´s experimental morphine pill Embeda is less susceptible to abuse than existing standard treatments. The FDA is scheduled to act on Alpharma's new drug application by December 30th under a six-month priority review status.
11-16-2008 |
10:14 hs.
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According to an FDA advisory panel, Alpharma Inc.´s experimental morphine pill Embeda is less susceptible to abuse than existing standard treatments. The FDA is scheduled to act on Alpharma's new drug application by December 30th under a six-month priority review status. A hidden chemical in Embeda called naltrexone may make it somewhat more difficult for abusers to get high by chewing or crushing the capsule. Some members of the advisory panel said advertising Embeda or any new painkiller as abuse-resistant would only encourage misuse. Embeda's core of naltrexone is activated when the drug is crushed or chewed, reducing the sense of euphoria given off by the morphine. It's unclear whether injections or another form of manipulation would override the safeguard. Embeda is an extended-release opioid painkiller designed to treat moderate to severe chronic pain. It also is designed to deter the kind of abuse seen with other opioid drugs such as Purdue Pharma´s Oxycodone. In October, Alpharma said results of the Embeda trial showed that 72.5 percent of patients taking the drug reported experiencing a 30 percent pain relief from where they started, compared with 57.8 percent of patients given a placebo. Earlier that month Alpharma reported that the FDA had given Embeda a priority review designation, meaning it would be reviewed in a time frame of six months. The application was filed on June 30th. Embeda may capture 4 percent of prescriptions for controlled-released opium-like painkillers if it is approved, according to analysts.
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