A few months ago we heard about a true innovation that made us hope for a definitive solution to the major problem of ephedrine and pseudoephedrine, which is their precursor role in the manufacture of methamphetamine: a relatively small drug company, Highland Pharmaceuticals, has set fireworks in the industry by announcing a new formulation process called Tarex™ which can produced “meth-resistant” pseudoephedrine.
How does it work to be meth-resistant?
The exploding rise of meth that has overwhelmed part of the Midwest, South and West is partly due to the fact that producing meth is relatively easy, especially with the “shake and bake” or “one pot” method. Meth cooks combine pills of pseudoephedrine with basic chemicals by shaking up the components in a 2-liter soda bottle. This process is very dangerous because the needed chemicals are highly flammable. A key step of the reduction of pseudoephedrine to meth is the crystallization phase when heated. This is where Tarex™ makes the difference: the process is stopped before crystallization can occur, due to the new formulation which turns the chemical solution into a gooey substance. “It kind of gunks up”, Highland Pharmaceuticals says.
Is it confirmed by officials?
The Drug Enforcement Administration has been very interested by this product, as it is a new proactive approach of fighting meth compared to classical methods: instead of chasing meth cooks, prevent them cooking meth! Preliminary testing of the Tarex™ process has been done, by using the same extraction method as used by meth makers. The results are positive at this stage and Highland Pharmaceuticals hope for a commercial launch of their product called Zephrex-D in early November, starting with pharmacies in the St. Louis area, close to the drug company’s headquarters.
Will it be sold over the counter?
For the moment, all sales of ephedrine and pseudoephedrine are strictly controlled: some states have passed laws requiring a doctor’s prescription and for the rest, retailers are asking customers to sign a form before purchasing ephedrine-based medications. Those using the NPLEX real-time tracking system even check if the purchased quantity is not exceeding the legal limit, which is a total of 3.6 grams per sale and 7.5 grams per month if delivered per mail or 9 grams if bought locally. Zephrex-D will begin its commercial life behind the counter as all other pseudoephedrine medications, but Highland Pharmaceuticals plans to sell it over the counter as soon as possible: they have already asked the DEA to exempt their product from the CMEA (Combat Methamphetamine Epidemic Act 2005) that forces to sell ephedrine-based medications behind the counter. But this might take time, from 6 months to 3 years, depending on the political treatment that this request will receive. We will come back to that point later.
These are great news, maybe the best since 2004. Until Highland Pharmaceuticals gets exemption, nothing will change regarding ephedrine for sale online and behind the counter, people suffering from cold, flu, allergies or asthma will not see the difference. But as soon as Zephrex-D will be available in stores shelves, it could be a game changer for ephedrine.
In our next post, we will try to analyze the possible consequences for all concerned people.