FDA approves Teva’s new formulation for emergency contraceptive
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.
Research finds elevated insulin levels in postmenopausal women may raise risk of breast cancer
NEW YORK Elevated insulin levels in the blood appear to raise the risk of breast cancer in postmenopausal women, according to researchers at Albert Einstein College of Medicine of Yeshiva University. Their findings were published in the online version of the International Journal of Cancer July 9.
Increased breast cancer risk for postmenopausal women has previously been linked to obesity and diabetes. Both conditions involve insulin resistance, which causes increases in circulating levels of insulin. Since insulin is known to promote cell division and enhance breast tumor growth in animal models, the Einstein scientists reasoned that relatively high insulin levels may contribute to breast cancer risk in women.
“Up to now, only a few studies have directly investigated whether insulin levels are associated with breast cancer risk, and those studies have yielded conflicting results,” stated Geoffrey Kabat, senior epidemiologist in the department of epidemiology and population health at Einstein and the lead author of the paper. “Those other studies were based on just a single baseline measurement of insulin, while our study involved analyzing repeated measurements of insulin taken over several years — which provides a more accurate picture of the possible association between insulin levels and breast cancer risk.”
An earlier study linking insulin levels with breast cancer risk was carried out by Einstein researchers and was published in the January 7, 2009 issue of the Journal of the National Cancer Institute.
In the most recent study, Kabat and his colleagues analyzed data on 5,450 women enrolled in the Women’s Health Initiative, a large multicenter study investigating the influence of a number of factors on women’s health. Most of the women had participated in the clinical trial portion of the study and provided fasting blood samples at the start of the study and then at years one, three and six. The remaining women, who were enrolled in a separate “observational” component of the study, provided fasting blood samples at baseline and at year three of the study. Among all these women, 190 cases of breast cancer were identified over eight years of follow-up.
The analysis by Kabat and colleagues revealed a strong association between elevated insulin levels and increased risk for breast cancer.
After dividing the participants into three groups based on their insulin levels, the researchers found that women in the upper third for insulin level were more than twice as likely to develop breast cancer, compared with women in bottom third for insulin level.
Notably, the link between elevated insulin level and breast cancer was strongest among lean women and weakest among obese women (who, in general, have higher insulin levels compared with lean women).
“This finding is potentially important because it indicates that, in postmenopausal women, insulin may be a risk factor for breast cancer that is independent of obesity,” Kabat said. However, because the number of lean women was small, this finding is preliminary.
While these results require confirmation from other studies, Kabat noted that the current recommendations for reducing breast cancer risk in postmenopausal women — including maintaining a healthy weight and engaging in regular physical exercise — can help to reduce insulin levels.
NAD recommends PatentHealth modify, discontinue advertising claims for dietary supplement
NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Thursday recommended that PatentHealth modify or discontinue certain claims for its Trigosamine Fast Acting dietary supplement, including speed of relief claims.
PatentHealth responded that it will appeal certain NAD findings to the National Advertising Review Board.NAD, the advertising industry’s self-regulatory body, examined advertising for Trigo FA following a challenge by Nutramax Laboratories. Claims at issue included:
- “Mom gets rapid relief from the new joint pill that works in just 3 days.”;
- “Trigosamine Fast-Acting has been clinically shown to get results in as little as 3 days. Participants continued to feel improvement throughout the 8 week trial”;
- “Just released clinical study says new pill works 600% faster than Glucosamine alone.”; and
- “2 caplet dose for fast, all day joint relief,” among others.
The advertised product is an addition to the advertiser’s line of joint-health products, and was introduced into the marketplace in 2008, NAD noted. In contrast to the original formula of Trigosamine, which contains glucosamine, chondroitin sulfate, and hyaluronic acid, Trigo FA contains a formula of glucosamine sulfate, hyaluronic acid and a “RapidFlex” proprietary blend, which includes trademarked Boswellin, patented Curcumin C3 Complex and patented Bioperine (a standardized extract of black pepper).As support for its performance claims, PatentHealth relied on a clinical study on Trigo FA that it commissioned to test the supplement’s efficacy in the management of osteoarthritis of the knee in comparison to placebo. The advertiser maintained that in the fall of 2008, its proprietary Trigo FA study was completed, and based upon the results, as well as the substantial body of scientific evidence for each of the individual ingredients in Trigo FA, PatentHealth developed its advertising claims for new Trigo FA.
Based on all of this evidence, NAD noted in its decision that it recognizes that glucosamine supplementation provides a benefit for sufferers of osteoarthritis, but not within the short time periods advertised for this product.
The claims of “rapid relief” and “fast acting” are based on the advertiser’s Trigo FA study which found that the subjects taking Trigo FA experienced a statistically significant (albeit small) increase in the distance walked from baseline as measured by a six-minute walk test, after three days of supplementation. In contrast, the placebo group in the study experienced a decrease in distance walked in the six-minute walk test at every measured interval. The advertiser maintained that this positive and statistically significant result evidences that the product can “work” for most in only three days, which is a quick result that can be referred to as a “rapid relief” and, therefore, this claim is properly substantiated.
NAD determined however, found that there was insufficient evidence to establish that the demonstrated improvement in the walk test is what consumers taking Trigo FA would expect or consider as the claimed “relief” promised in three days. NAD recommended that the advertiser discontinue using the term “rapid relief,” since there was insufficient evidence that the results achieved in the Trigo FA study would be considered by consumers to be “rapid relief.”
Further, citing concerns about the parameters of the walk test, NAD recommended that the advertiser discontinue claims based on the results of the test as measured after three days.
NAD also recommended that the advertiser discontinue the claim “2 caplet dose for fast, all day joint relief.”
NAD also fielded two primary concerns about the truthfulness and accuracy of the comparative superiority claim that Trigosamine works 600% faster than glucosamine alone. First, the Trigo FA study relied upon by the advertiser did not compare Trigosamine FA with glucosamine. Rather, the advertising relied on the results of results of its Trigosamine FA testing against a placebo, compared to the results of other studies conducted on glucosamine alone. Making such a study-to-study comparison is not appropriate because of the different study populations, and other variables involved within each study. Given the uncontrolled variability within studies and between the studies, a claim based on such a comparison is inherently unreliable.
Further, NAD determined that the express language of the claim which reasonably implies that the “just released clinical study” specifically found that Trigo FA works 600% faster than glucosamine alone, a message which misstates the results of the study.
NAD recommended that because there is currently no testing comparing the efficacy of Trigo FA supplementation with that of glucosamine supplementation alone, any comparative efficacy and/or performance claims of Trigo FA versus glucosamine should be discontinued.
The company, in its advertiser’s statement, said it would appeal NAD’s decision related to claims based on the results of the Six Minute Walk Test, measured at the three day data point, as well as NAD’s findings related to appearance of advertising.
“PatentHealth believes that the NAD has misunderstood the meaning of its statistical analysis and the data underlying the three-day claim, which led the NAD to reject this claim,” the dietary supplement supplier stated. “This misunderstanding surrounding the meaning of baseline and raw data should not change the fact that credible statistical analysis proves there was a statistically significant improvement in mobility at the Day 3 data point. Therefore, PatentHealth will seek the NARB’s review of this claim.”
The company said, as well, that it will comply with NAD’s recommendation regarding claims of “fast” or “rapid relief;” ”600% faster than glucosamine” and any direct glucosamine comparison claims; and “…when combined with glucosamine, improves absorption of nutrients and works quickly to improve mobility and flexibility.”