Goods news for cold, allergy and asthma sufferers, bad news for meth cooks!
Do you remember this post, Ephedrine For Sale Over the Counter Again? It was about a new generation of pseudoephedrine pills: Zephrex-D from Highland Pharmaceuticals has a special formulation process called Tarex™, making these tablets impossible to be turned into meth: crystallization is blocked during the ‘shake and bake’ or ‘one pot’ methods of making meth, when heated the chemical solution turns into a gooey substance.
After all these years, deploring that a minority of drug addicts was depriving honest people from all the benefits of ephedrine and pseudoephedrine, not only as decongestant but also for weight loss, honestly we were quite excited by these news: for the first time since the FDA ban on ephedrine in 2004 we had a hope that this new proactive approach based on science, not law enforcement, could be a real game changer, even leading to ephedrine for sale over the counter as before the ban. Within the team we have been doing some political fiction: Ephedrine Sold Over the Counter, A Political Fiction, trying to foresee all the changes that this game changer would have for all involved parties: politicians, pharmaceutical industry, meth cooks, law enforcement officers, doctors and pharmacists and patients of course.
Regarding the pharmaceutical industry, our guess was that this breakthrough innovation had severely weakened the position of all pharmaceutical companies involved in pseudoephedrine medications, compared to Highland Pharmaceuticals: first the new generation is leaving them without arguments in front of politicians who want to pass laws requiring prescription for ephedrine, making everybody (drug agents, patients, doctors and pharmacists) very happy except producers. Second point: they have to react to the new competition, either by investing in new formulations or by paying royalties to use Tarex™. In all cases they are losing profits.
Apparently we were right, some pseudoephedrine producers have started to adapt. We were curious to know more about the price that Highland Pharmaceuticals was going to ask for the use of their formulation: it’s not official but we have heard that it could be about 2 cents a pill. Not a big deal for companies who don’t want or can’t invest in research. There is more: Tarex™ is not the only player anymore, Acura Pharmaceuticals, based in Illinois, has developed a proprietary process called Impede™ Technology that limits or disrupts the extraction of ephedrine from tablets for conversion into methamphetamine. Good to have competition!
In fact Acura Pharmaceuticals could have been the first company launching a meth-deterring pseudoephedrine but they failed one year ago during a test performed by scientists working with a law enforcement agency: there are 3 common methods to produce meth out of pseudoephedrine and in one test method an unknown amount of methamphetamine, with unknown purity, was produced. Acura Pharmaceuticals decided to delay its commercialization activities for one year and now they come again with a product called Nexafed.
Is Nexafed really meth-resistant?
Unfortunately the Impede technology is not fully meth-proof: compared to a traditional pseudoephedrine tab, approximately half as much methamphetamine can be extracted from Nexafed when using the ‘shake-and-bake’ or ‘one-pot’ method (mixing the pills with volatile chemicals and shaking them together in a plastic bottle). When using other extraction methods, the Impede technology works fine, no meth can be produced from Nexafed. The argument of Acura Pharmaceuticals in order to relativize their results with the ‘shake-and-bake’ or ‘one-pot’ method is that it makes it less profitable for meth cooks… We are not sure that this argument will convince the Officials to get exemption from the federal Combat Methamphetamine Epidemic Act (CMEA).
Highland Pharmaceuticals had better results: no labs would test Zephrex-D with the ‘shake-and-bake’ or ‘one-pot’ method because it’s too dangerous, so the Missouri Narcotics Unit did the tests with several combinations of chemicals and none of them produced meth.
Good point for Acura’s product: a Phase 1 pharmacokinetic study in 30 healthy adult subjects has confirmed that Nexafed has the same effectiveness than other pseudoephedrine-based medications. The Impede technology does not compromise the effectiveness of the active ingredient, it is bioequivalent to Johnson & Johnson’s Sudafed® which is a reference. Acura’s president, Bob Jones, says that the product’s resistance to meth conversion was only a second priority, after medical effectiveness: “This isn’t about law enforcement, primarily. It’s about the consumer. If we make products available to the consumer that don’t work for them, we haven’t really fixed the problem”. Let’s give Acura the advantage over Highland here.
Good point again for Nexafed: you remember that Zephrex-D from Highland Pharmaceuticals was planned to be sold 10% higher than standard pseudoephedrine, it is not the case for Nexafed which is expected to be positioned at the same price than Sudafed®.
Ephedrine for sale over the counter?
We see many positive points in this announcement:
- It is good to have a second player next to Highland Pharmaceuticals: competition profits to all.
- We have a medical study confirming that meth-proof ephedrine can be as effective as ordinary products.
- Same pricing as Sudafed® proves that these new products can be profitable despite the extraction-resistant formulation: no extra cost for honest patients and a contribution in the fight to curb the illicit manufacture of methamphetamine.
Acura has now to hope that Nexafed can break free of the pharmacy counter to true OTC status, knowing that their product is not fully meth-resistant with the ‘shake-and-bake’ or ‘one-pot’ recipes. Highland Pharmaceuticals has a clear advantage in the race to exemption from the Combat Methamphetamine Epidemic Act. Both products, Zephrex-D and Nexafed, will likely remain behind the counter for at start, but if they get federal clearance then people will be able to buy ephedrine not only online and in pharmacies but also in gas stations, convenience stores or anywhere else.
Back to the future