HEALTH

Harvard School survey asserts NRT ineffective in spite of body of evidence to the contrary

BY Michael Johnsen

BOSTON — Nicotine replacement therapies designed to help people stop smoking, specifically nicotine patches and nicotine gum, do not appear to be effective in helping smokers quit long-term, even when combined with smoking-cessation counseling, according to a new survey by researchers at Harvard School of Public Health and the University of Massachusetts Boston posted in an advance online edition of Tobacco Control Monday.

"What this study shows is the need for the Food and Drug Administration, which oversees regulation of both medications to help smokers quit and tobacco products, to approve only medications that have been proven to be effective in helping smokers quit in the long-term and to lower nicotine in order to reduce the addictiveness of cigarettes,” stated co-author Gregory Connolly, director of the Center for Global Tobacco Control at HSPH.

The study, with only 787 interviewees, pales in comparison to the body of research encompassing more than 35,000 subjects that does establish appropriate efficacy. Participants were asked whether they had used a nicotine replacement therapy in the form of the nicotine patch (placed on the skin), nicotine gum, nicotine inhaler or nasal spray to help them quit, and if so, what was the longest period of time they had used the product continuously. They also were asked if they had joined a quit-smoking program or received help from a doctor, counselor or other professional.

"Despite the authors’ conclusions, there remains strong support for NRT’s efficacy and its positive impact on public health," countered GlaxoSmithKline, manufacturer of Nicorrette, in a statement released Monday. "Leading experts in the field of smoking control, nongovernmental bodies, such as the World Health organization, and many governments around the world, agree that NRT products have a crucial role to play in helping to reduce the devastating toll of disease caused by tobacco dependence," GSK stated. "Additionally, the 2008 U.S. Public Health Service Guideline, ‘Treating Tobacco Use and Dependence,’ recommends NRT products as a first-line therapy for quitting, as they ‘increase significantly rates of long-term smoking abstinence.’"

According to the Harvard School survey, almost one-third of recent quitters reported to have relapsed. The researchers found no difference in relapse rate among those who used nicotine replacement therapy for more than six weeks, with or without professional counseling. No difference in quitting success with use of NRT was found for either heavy or light smokers. GlaxoSmithKline added that 97% of those smokers who attempted to quit "cold turkey" also relapsed and began smoking again.

"When it comes to smoking cessation, there is no ‘magic pill’. Quitting smoking requires a combination of pharmacotherapy and behavioral support," GSK stated.

 


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E.Oppenheim says:
Jun-15-2012 11:47 am

When individuals mention narcotics abuse, they typically describe drugs (prohibited or prescribed) and alcohol. Although our culture takes into account the routine of cigarette smoking cigs to be nicotine addiction, this routine does not get classified with additional dependencies. Individuals do work to stop cigarette smoking cigs, however there are additionally non-prescription therapies you can easily get without getting into addiction recovery programs. Many individuals that are grappling with some sort of addiction, be it to an illegal drug, such as heroin or an addiction to particular habits like betting or eating way too much, additionally smoke cigs. In some addiction recovery programs, cigs are utilized as an enticement to lead clients away from narcotic dependency.

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Perrigo forecasts sunny days now and in the future for private-label OTC

BY Michael Johnsen

NEW YORK — Over the past year, store-brand sales of over-the-counter products have helped maintain a slight growth through the sector, and with the number of proposed prescription-to-OTC switches on the horizon, the future looks especially bright, Joe Papa, Perrigo chairman, president and CEO, told attendees of the 30th Annual J.P. Morgan Healthcare Conference held here Monday.

According to Papa, total private-label OTC sales were up 6.4% through Dec. 18, versus a 2.5% decline in the sale of branded items that netted a plus-0.3% in overall category growth. A lot of that can be attributed to the McNeil Consumer recalls in the past two years, and McNeil has reported its brands would fill shelves and supply chains once again no later than mid-2012, Papa reported. "They’ve talked about reentering into the liquid market in October, November December of 2011 and they said they would reenter in the oral solid market January, February March of 2012 with a complete return sometime around midyear 2012," Papa said. "I will say that the liquids at this time, they’re not fully back … they’re not completely back at this time for example in the Tylenol suspension."

And while McNeil’s return to market is expected to be charged by a significant consumer ad spend later this year, a factor that may turn sales of branded OTCs overall favorable, Papa was still bullish regarding store brand OTC products for two reasons — profit margins and switch. Papa noted that typical private-label margins exceed 50% versus 20% yielded from the branded equivalents. "Critical to this equation though is also the saving for the consumer. Usually there’s about a 25%, 30% saving for the consumer and this is in essence the reason we exist. We are same quality and effectiveness in terms of our manufacturing capabilities, but offer the consumer about a 25% to 30% saving and obviously much higher margin for the retailers and this is really what’s driving the profitability for the retailers and why they continue to give us more shelf space for the products."

Looking forward, Papa said Perrigo has more than 45 new products in the hopper, representing more than $190 million of revenue for the company’s fiscal 2012. "We have a generic version of Clarinex, [though it’s] unclear whether that will be a prescription product or an OTC, he said. Other OTC store brands expected to launch in the next six months include Prevacid, Deson, Allegra D-12, Mucinex, Claritin D and Rogaine Foam.

Beyond that, Papa projected between $10 billion to $15 billion worth of prescription sales will transition to the over-the-counter market. "We are really excited about what it means for the future for us," he said. "We’ll launch our version of Prevacid later this year in May of 2012, but also then the rest of the proton inhibitors like Nexium, Protonix, Aciphex are all examples of potential switch candidates and then we think of some other exciting ones like potentially Voltar and topical gel Diclofenac Gel, all representing good switch candidates to move from prescription status to OTC that will help drive our growth beyond just the next 12 months."


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Endo addresses possible short-term supply of Opana ER, other drugs

BY Allison Cerra

CHADDS FORD, Pa. — Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.

"We are working collaboratively with the [Food and Drug Administration] to minimize the disruption to patients currently on therapy. Given existing inventories, the expected restart of Novartis production and our ability to shift production to other facilities we believe the supply constraints of our products should be limited," Endo COO Julie McHugh said. "With Novartis as the sole manufacturer of the current formulation of Opana ER, we plan to temporarily moderate demand of the product by asking physicians to refrain from starting new patients on Opana ER in order to minimize disruption for patients currently on the product. We currently expect this to be a short-term issue and we remain focused on working with the healthcare community to optimize the continued supply of our products for current patients."

The following products may experience a short-term supply constraint include:

  • Opana (oxymorphone hydrochloride) tablets CII;

  • Oxymorphone hydrochloride tablets CII;

  • Percocet (oxycodone hydrochloride and acetaminophen USP) tablets CII;

  • Percodan (oxycodone hydrochloride and aspirin, USP) tablets CII;

  • Endocet (oxycodone hydrochloride and acetaminophen USP) tablets CII;

  • Endodan (oxycodone hydrochloride and aspirin, USP) tablets CII;

  • Morphine sulfate extended-release tablets CII; and

  • Zydone (hydrocodone bitartrate/acetaminophen tablets, USP) CIII.

As previously reported, Novartis Consumer Health suspended production at its Lincoln, Neb.-based facility to implement manufacturing process improvements, which will address possible rare instances of errors in production.


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