Cocaine Treatment Gives Investors A High
4 CommentsBy Ed Silverman // December 7th, 2007 // 4:34 pm
Nostrils were wide open on Wall Street today to take in the results of a study for vigabatrin, an experimental med that is being tested to fight cocaine addiction. Shares in Catalyst Pharmaceuticals rose more than 11 percent following publicity about a Phase II study showing the drug worked in a meaningful number of patients, who were prison parolees.
The results indicated a statistically significantly greater number of patients given vigabatrin were able to abstain from cocaine during the last three weeks of the dosing period, compared to those receiving placebo. The primary outcome measure of the trial was negative urine tests for cocaine for the last three weeks of the nine-week trial, and a total of 18 patients, or 42 percent of the 103 who were enrolled, fulfilled the criteria. Of these, 14, or 28 percent, were treated with vigabatrin versus four, or 7.6 percent, who were treated with placebo.
“Typically, in anti-addiction trials of this size the difference between drug and placebo groups is expected to be approximately 30 percent, a level that may not necessarily translate into clinical meaningfulness subsequently,” writes Elemer Piros, a biotech analyst at Rodman & Renshaw, in an investor note. “The study demonstrated a high level of statistical significance, regardless of whether the statistical analysis of the primary endpoint included covariates (number of years of cocaine use and average amount of cocaine use at baseline) or not.”
The drug, by the way, works by indirectly lowering the level of dopamine in the brain, which causes the high associated with drug abuse. Catalyst says it expects initial top-line results of the Phase II clinical trials to be available during the summer of 2008, and also plans to have the full data set presented at scientific meetings next year. Meanwhile, Phase II trials for methamphetamine addiction are supposed to begin next year.
greg
This can help those that feel they need a drug to save them from addiction, but different things work for different people. Some people need full programs to recover from drug addiction, and sadly they don’t always get the attention they need.
This is why the A&E show Intervention is so important. It demonstrates how difficult addiction can be and uses a highly qualified team of specialists to address the core issues. check out http://www.aetv.com/intervention The show really does a great job of showing what it takes to get on the road to recovery for some of the most difficult addictions and how it affects everyone around the addict. I’m working to help promote the show because I believe that helping others with their addictions is an important issue. See for yourself when a new episode airs every Monday night at 8:00pm/9:00central
Jack
Did anyone see 60 minutes last night? A businessman was trying to peddle 3 off-patent drugs in combination (gluphenazil, gabapentin and hydroxyzine) in combination to combat meth addiction. He went about his business without FDA approval, and without submitting any double-blind, placebo-controlled trials to the FDA. He said numerous times that since he knows the drug works and meth addiction destroys lives he can’t wait for FDA approval. I couldn’t help but think, “they still test cancer medications.”
I didn’t really understand how he made money off of it though (since all the drugs come generic). As best as I could tell, I think he “sold” the knowledge of the dosing regiment to the doctors.
George
Gabapentin process patent has been re-instated.
http://www.orangebookblog.com/2007/09/pfizer-wins-app.html
He’s gonna have the big P knocking on his door.
Garden Fountain Freak
Garden Fountain Freak…
And how is it working for you, it has been some time between now and this post, i was just wondering if you are happy with it….