HEALTH

FDA approves Teva’s new formulation for emergency contraceptive

BY Michael Johnsen

NORTH WALES, Pa. Teva Pharmaceuticals on Monday announced that the Food and Drug Administration has approved Plan B One-Step as an over-the-counter emergency contraceptive for females ages 17 and older. The new Plan B One Step is the former two-pill regimen — used to help prevent an unintended pregnancy after unprotected sex or contraceptive failure — now as just one pill in one dose.

OTC availability for women ages 17 is new as well — a federal judge ordered FDA to lower the OTC age limit for Plan B from 18 to 17 in April, though the agency noted it would need a new drug application from Teva in order to accomplish that.

Plan B One Step will begin shipping by August, Teva reported.

“With Plan B One-Step, emergency contraception is now available in just one pill that can be taken right away when the unexpected happens,” stated Amy Niemann, general manager and SVP of Teva Women’s Health. “We’re proud to offer women this new, innovative emergency contraceptive option that builds upon the trust that women have come to know with Plan B.”

“I prefer one-pill dosing for my patients because it allows them to act more quickly, while providing a high level of safety and efficacy,” commented Ashlesha Patel, division director of Family Planning Services, John H. Stroger, Jr., Hospital. “Emergency contraception is more effective the sooner it’s taken, and Plan B One-Step provides a back-up plan that’s just one pill away.”

Awareness of Plan B has increased significantly since OTC approval in 2006, Teva reported. More than 88% of 18-to-30-year-olds categorize Plan B as emergency contraception, up from 64% in 2006. And 86% of individuals understand that the product prevents rather than terminates pregnancy, unlike the prescription “abortion pill” RU-486.

Additionally, U.S. retail pharmacists are overwhelmingly compliant with dispensing guidelines. Within one year post OTC approval, 99% of pharmacists who sold Plan B were aware of its dual-label status (it’s prescription-only for women younger than 17) and 95% were comfortable selling/dispensing Plan B.

Teva’s original Plan B formulation was opened to generic competition last month, as Watson Laboratories obtained approval for its Next Choice levonorgestrel brand, though only as a prescription for women younger than 17. Teva has patent protection on the OTC indication through Aug. 24.

For the 12-months ended March 2009, Plan B had total U.S. sales of approximately $123 million, of which approximately 10% are attributable to prescription sales, Watson reported, citing IMS sales data.

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HEALTH

Study finds patients that have dry mouth use multiple medications

BY Michael Johnsen

BALTIMORE Approximately 91% of dentists report that patients who are complaining about dry mouth are taking multiple medications, according to a nationwide member survey conducted by the Academy of General Dentistry released Thursday.

“The number of [dry mouth] xerostomia cases has increased greatly over time because people are taking more and more medications,” stated Cindy Kleiman, who presented the study. “General dentists are seeing this trend in their offices, which is why they are trying to learn all they can about this condition. The more they know, the better they will be at diagnosing and treating patients.”

Dry mouth, or xerostomia, is caused by a decrease in salivary function. It affects approximately one in four Americans, placing more than 25% of people at risk for tooth decay. There are more than 400 prescription and non-prescription drugs associated with xerostomia, according to Raymond Martin, a dentist. “Anti-depressants, painkillers, diuretics, antihistamines, tranquilizers and anti-hypersensitives can all contribute to dry mouth,” he said. “People who take several of these medications are more susceptible.”

As indicated by the AGD survey, the most common symptoms reported by patients include constant thirst and difficulty eating, swallowing or speaking. Foamy or stringy saliva, irritation of the tongue, burning of the tissues inside the mouth, painful ulcerations and dentin hypersensitivity (extreme sensitivity in one or more teeth) are also dry mouth symptoms. Over time, xerostomia sufferers may experience extensive tooth decay, tooth loss or gingivitis due to the lack of saliva.

Out of the nearly 500 general dentists who responded, 89% believe prescription medications are the primary contributor to dry mouth. Aging, dehydration and salivary gland disease were also cited as major contributors. Approximately 68% of the dentists said constant thirst is the most common symptom communicated by patients; 44% said patients have difficulty eating, swallowing or speaking. More than 92% reported that patients attempt to increase salivary production by drinking water; less than 58% reported patients tried taking over-the-counter saliva substitutes, chewing sugar free gum or sucking on hard candy.

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ERSP determines Swiss Labs reliable support for dietary supplement claims

BY Michael Johnsen

NEW YORK The Electronic Retailing Self-Regulation Program on Thursday determined that Swiss Labs provided reliable support for certain claims around the company’s Arthri-Zen Relief dietary supplement, but recommended the marketer modify certain claims.

ERSP examined claims in broadcast and online advertising that included:

  • “Imagine 24-HOUR JOINT RELIEF!”;
  • “Arthri-Zen eases: joint discomfort; muscle and tissue aches; sleepless nights; stiffness and swelling”;
  • “Arthri-Zen Relief is clinically proven effective in the relief of joint and muscle discomfort.”;
  • “…And natural products like Glucosamine and Chondroitin just don’t work.”; and
  • “With its unique delivery system Arthri-Zen Relief works quickly and effectively. You’ll feel a difference immediately.”

Following its review, ERSP determined that the marketer’s clinical study provided adequate support for the marketer’s claims that the product could reduce joint and muscle discomfort when used as directed. However, given that a single study was performed, ERSP recommended that the marketer discontinue any reference to “clinical studies.”

ERSP noted in its decision that the marketer’s study indicated that 53% of the trial subjects who received the Arthri-Zen formulation experienced significantly less pain by the fourth day of the trial. ERSP noted that relief following four days of treatment is not consistent with consumers’ expectations of a product that advertises “immediate” relief. The marketer asserted that it would modify the claim, “immediate relief.”

ERSP further noted that that the marketer’s “24-HOUR JOINT RELIEF” claim could be interpreted by consumers as a reference to a systematic release of the product’s primary ingredients throughout the day. ERSP recommended that the marketer modify the context of the claim to clarify for consumers its intended message that users of the product can experience relief for up to 24 hours in between dosages.

Further, ERSP determined that, based upon the evidence presented by Swiss Labs it is inaccurate to categorically conclude that glucosamine and chondroitin provide no therapeutic benefits and noted that the advertiser has asserted it will voluntarily discontinue comparative claims involving glucosamine and chondroitin. ERSP recommended the marketer not disseminate the same or similar claims in future advertising for Arthri-Zen Relief.

“While we believe that all of our advertising is fully substantiated, we have decided to accept ERSP’s recommendations in its entirety and will make the minor recommended modifications to our advertising,” Swiss Labs stated. “Swiss Labs appreciates the insight and expertise provided by this process and will take this guidance into consideration in future advertising.”

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