Guest guest Posted December 9, 2008 Report Share Posted December 9, 2008 Just searched the news (see below) ... there's a new drug that combines morphine and naltrexone - this type of drug would have to be listed as a 'controlled substance' due to the morphine component. .... FDA Sees a Small Advance With Alpharma Painkiller By JENNIFER CORBETT DOOREN NOVEMBER 16, 2008, 10:01 P.M. ET A Food and Drug Administration panel said on Friday that a new, proposed formulation of an Alpharma Inc. morphine pill was a " small advance " that could be less susceptible to abuse and misuse than similar pain pills on the market. The drug, Embeda, is a controlled-release form of morphine designed to cut down on abuse. Many drug abusers break down controlled-release pain medicines by dissolving pills in alcohol and injecting the mixture to get all the effects at once, creating a heroin-like high. Controlled-release drugs like morphine or drugs such as OxyContin with a different active ingredient, oxycodone, are supposed to be swallowed whole and have pain medicine released over 12 hours. Alpharma, based in Bridgewater, N.J., designed Embeda by combining morphine with naltrexone, which limits the effectiveness of morphine because both chemicals act on the same receptors in the brain if the pill is broken or tampered with. If swallowed as directed, the naltrexone component is designed to stay inside the tablet and then pass through the gastrointestinal tract, thereby allowing the morphine to act as intended. The issue isn't whether Embeda works to treat pain; it is whether the drug could be approved and labeled as a product that could cut abuse. While the panel didn't take a vote on whether it thought Embeda should be approved, many panel members said they thought it might offer an incremental advance at deterring prescription-drug abuse. The FDA is expected to make a decision on Embeda by Dec. 30. Alpharma conducted two studies in people that looked at whether they felt " high " after taking a combination of morphine and naltrexone, morphine alone or placebo. People taking straight morphine were more likely to report feeling high than those taking morphine combined with naltrexone. However, the FDA said it was concerned that drug abusers could figure out a way to separate the morphine and naltrexone components of the drug. The agency also said it wasn't clear what would happen if Embeda was crushed and snorted or chewed. ph Stauffer, Alpharma's chief medical officer, said a " very determined abuser " could manipulate the pill. But, he said, " We believe this medication provides roadblocks. " Most panel members agreed with the company that Embeda could be harder for drug abusers to tamper with. " It's an advance, but it's a small advance, " said Nussmeier, a professor at State University of New York in Syracuse. " We didn't hear anything about potential for chewing or snorting or heating it or cooking it. " In September, King Pharmaceuticals Inc., Bristol, Tenn., made an unsolicited offer to acquire Alpharma that is pending until Friday. Alpharma's board of directors has recommended that shareholders reject the King offer. http://online.wsj.com/article/SB122688917223832613.html?mod=googlenews_wsj LDN IMPORTS Hi Celia, There's been a little agitation in the news here in Oz - around a Naltrexone implant. Essentially, pharmaceutical and manufactured products that treat addiction are either being trialled at present, or are in the product pipeline. In a commercialised environment, pre-marketing and anti-competitive behaviour are sometimes employed, and sadly, the health industry is a fully commercialised environment. Makes me think there could be a new product on the horizon, Cris 7a. LDN IMPORTS Posted by: " Celia " celia@... redharvester2001 Date: Mon Dec 8, 2008 10:44 am ((PST)) I have just heard that LDN is going to be stopped being imported to GB, has anyone else heard of this? Thanks Celia Quote Link to comment Share on other sites More sharing options...
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