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Quit Smoking with Tabex
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As health care costs continue to spiral, getting smokers to quit becomes more and more important. The incidence of cardiovascular disease, COPD, and various cancers have their roots in nicotine addiction, making new ways to curb smoking of major interest. Thus, when an article appears in the Washington Post touting a “pill that quashes tobacco urge found in plain sight,” it gets attention.

The article focuses on the efforts of entrepreneur Rick Stewart, who is developing a drug that “works by interrupting tobacco cravings, much like

’s top-selling Chantix, but possibly without that drug’s high-profile side effects and at a much lower price.” Furthermore, the product grows on trees – literally. The drug is cytisine and it is isolated from laburnum trees in Bulgaria. In fact, it is already sold as Tabex by Sopharma in Eastern Europe, where it’s been on the market since 1964.  Furthermore, there have been clinical studies done recently that support the smoking cessation properties of cytisine when compared to placebo.

Stewart believes that there is great potential in this “really old, novel drug.” He struck a deal with Sopharma to get the drug approved in Western Europe and the United States. Rather than using the Sopharma name for the drug, Tabex, he is calling it “Extab” and he has raised capital to carry out the necessary steps needed to get regulatory approval. One might think that garnering such approval should be a breeze. After all, this drug has been in use in Eastern Europe for over 50 years. However, information in an extensive review by Jean-Francois Etter on the use of cytisine for smoking cessation suggests that there might be some hurdles. While Tabex had been available in all former socialist countries in the 1960s, it was withdrawn from the market in those countries that joined the European Union. The reasons are unclear, but Etter indicates that Sopharma acknowledges a number of drug side-effects including changes in taste and appetite, headache, nausea, and digestive problems. In addition, the drug is contraindicated for people with arterial hypertension and advanced atherosclerosis, conditions that some smokers have. All drugs have side-effects and cytisine is no different. But regulatory agencies like the FDA may want a better understanding of these effects before approval.

To obtain the data that will be required for approval, some clinical studies might need to be done. The FDA might even request that a head-to-head comparison study in smokers be done with Pfizer’s Chantix, which won’t come cheap. This is just speculation, but such a trial might require three study arms with 1,000 patients on Extab, 1,000 on Chantix, and 500 on placebo. Such a comparison has never been done and would be extremely valuable for patients, physicians, and payers concerned with getting smokers to quit.

However, if such studies are needed to get Extab approved, they will require millions of dollars. Stewart and his investors clearly desire a significant return on their investments to justify moving this program forward. Currently, Tabex is pretty cheap as Sopharma prices it at $29.99 for 100 tablets. But to recoup the investment and turn a significant profit for his investors, Stewart will have to charge a lot more than that. This is exacerbated by the fact that Extab will only have five years of market exclusivity as a novel drug in the U.S. thanks to the 1984 Hatch-Waxman Act. Further increasing the commercial challenge is that Stewart estimates that it will take as many as five years to get FDA approval. Thus, this drug might make it to patients by 2020. However, Pfizer’s Chantix patent expires by 2022, so Stewart’s Extab will be competing with a generic product that could be priced less than his drug.

Is this product going to live up to its promise of a safer alternative to current treatments like Chantix and buproprion? Perhaps – but that  still needs to be proven. Will it be cheaper? Maybe initially, but there will be a narrow window for a successful commercialization. Do great new smoking cessation products really grow on trees? We’ll see.