Even though the drugmaker designed its new Embeda opioid painkiller to curb misuse, FDA staff say it may not be enough. That's because Alpharma tested the effects of its design only when the pill was misused orally, but addicts tend to crush such morphine-based drugs and then inject them, FDA staffers wrote inbriefing materials prior to an advisory panel to be held on Friday.
"Thus, it is unknown what the potential effects of injecting this product following manipulation," they wrote. "The misuse and abuse of this product via injection has not been studied...Injection is the most commonly reported route of administration when these products are abused, and the most prevalent method of manipulation was crushing. Since (Alpharma) only tested the effects of manipulation orally, we recommend consideration be given during evaluation of the application as to whether these known methods of misuse and abuse are impacted by the abuse deterrents in Embeda."
Morphine-based drugs are often sought by drug abusers. Pills can be crushed or dissolved and then snorted or injected for a quick high. Embeda capsules include an inner core of naltrexone, which is a drug used to offset morphine, and the core is activated when crushed or dissolved, but does not counteract the morphine if the capsule is taken as directed, Alpharma wrote in separate documents. The drugmaker claims its extended-release pill makes it tougher to abuse.
Alpharma and others are trying to develop new types of drugs that are not as easily manipulated by drug abusers, which was a problem for Purdue Pharma and is OxyContin painkiller. Along with Alpharma, another drugmaker entering this market is King Pharmaceuticals, which appears before an advisory committee for its Remoxy drug tomorrow and is attempting a hostile takeover of Alphama.