HEALTH

C&D expands its First Response brand into multivitamins

BY Michael Johnsen

EWING, N.J. — Church & Dwight is leveraging its First Response brand into the dietary supplement set with the launch of First Response multivitamin gummies which target reproductive health and prenatal/post-natal need states. 
 
“First Response has been a trusted resource for women for more than 25 years, delivering her the innovative tools she needs to be prepared and knowledgeable throughout her reproductive health journey – a journey that extends well before pregnancy through post-pregnancy,” said Stacey Feldman, VP marketing, Church & Dwight. “As the category leader, First Response remains committed to reducing the anxiety faced throughout the family planning process by giving women a full breadth of products needed to make informed, healthy decisions. Expanding our portfolio to include women’s health vitamins allows us to meet yet another crucial need, extending our support throughout a woman’s reproductive years. ”
 
First Response multivitamin gummies were developed to provide women with the recommended amount of folic acid in an easy-to-consume gummy form. 
 
The two new vitamin SKUs, First Response Reproductive Health Multivitamin Gummies and PreNatal & PostNatal Multivitamin Gummies, will be available in drug, grocery and mass retailers across the country starting in April for $14.99. The First Response Reproductive Health Multivitamin Gummy is a multivitamin with essential nutrients needed for overall health and to help prepare for pregnancy (including 400 mcg of folic acid and 50mg of Omega-3 DHA).

One serving is an excellent source of iodine to support pre-pregnancy health. And the First Response PreNatal & PostNatal Multivitamin Gummy is a multivitamin that contains essential nutrients important to pregnant and nursing women (including 800 mcg of folic acid and B vitamins for energy metabolism support) and one serving is a good source of calcium for nursing mothers.

 
The supplements were developed in conjunction with C&D's Vitafusion, one of the leading gummy vitamin brands. 
 
“All women trying to get pregnant or who don’t use effective contraception 100% of the time during sex, should take a daily multivitamin with 400 mcg of folic acid,” said Mary Jane Minkin, clinical professor of obstetrics, gynecology and reproductive sciences at the Yale School of Medicine. “Folic acid has been found to be instrumental in helping to prevent neural tube defects, which often develop before a woman knows she is pregnant. The nutrients and vitamins in the First Response women’s health gummy vitamins are important for preparing a woman's body for a healthy pregnancy, even before they consider trying to conceive.”  
 
The full portfolio of First Response products includes at-home pregnancy test kits (including the Gold Digital Pregnancy Test), ovulation kits (including the Daily Digital Ovulation Test) and Pre-Seed, a sperm-friendly fertility lubricant. 
 
In addition, the First Response Tracker smartphone app offers personalized period and ovulation trackers, as well as a due date calculator.
 

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Research: Vitamin D may slow progression of low-grade prostate cancer

BY Michael Johnsen

 

DENVER — Taking vitamin D supplements could slow or even reverse the progression of less aggressive, or low-grade, prostate tumors without the need for surgery or radiation, Bruce Hollis, a researcher at the Medical University of South Carolina, reported Sunday at the 249th National Meeting & Exposition of the American Chemical Society here.
 
If a tumor is present in a prostate biopsy, a pathologist grades its aggressiveness on a scale known as the Gleason Grading System. Tumors with Gleason scores of 7 and above are considered aggressive and likely to spread, requiring surgical removal of the prostate gland (prostatectomy) or radiation therapy. In contrast, prostate tumors with Gleason scores of 6 and below are less aggressive, and in some cases may cause no symptoms or health problems for the duration of the man’s life.
 
In cases of low-grade prostate cancer, many urologists do not treat the disease, but instead do what’s called “active surveillance,” Hollis noted. “The cure — meaning surgery or radiation — is probably worse than the disease, so they wait a year and then do another biopsy to see where the patient stands.”
 
However, knowing that they have even low-grade prostate cancer can cause patients and their families excessive anxiety, which prompts some of the men to undergo an elective prostatectomy, despite the risk of complications such as infection, urinary incontinence and erectile dysfunction. But a man must wait 60 days from the time of his biopsy before he can undergo a prostatectomy, so that inflammation from the biopsy can subside.
 
Hollis wondered if giving these men vitamin D supplements during the 60-day waiting period would affect their prostate cancer. His previous research had shown that when men with low-grade prostate cancer took vitamin D supplements for a year, 55% of them showed decreased Gleason scores or even complete disappearance of their tumors compared to their biopsies a year before.
 
In a new randomized, controlled clinical trial, his team assigned 37 men undergoing elective prostatectomies either to a group that received 4,000 U of vitamin D per day, or to a placebo group that didn’t receive vitamin D. The men’s prostate glands were removed and examined 60 days later.
 
Preliminary results from this study indicate that many of the men who received vitamin D showed improvements in their prostate tumors, whereas the tumors in the placebo group either stayed the same or got worse. Also, vitamin D caused dramatic changes in the expression levels of many cell lipids and proteins, particularly those involved in inflammation. “Cancer is associated with inflammation, especially in the prostate gland,” Hollis said. “Vitamin D is really fighting this inflammation within the gland.”
 
The protein most strongly induced by vitamin D was one called growth differentiation factor 15. Previous studies by other groups showed that GDF15 dials down inflammation, and many aggressive prostate cancers make little or no GDF15.
 
The new research suggests that vitamin D supplementation may improve low-grade prostate cancers by reducing inflammation, perhaps lessening the need for eventual surgery or radiation treatment. “We don’t know yet whether vitamin D treats or prevents prostate cancer,” says Hollis. “At the minimum, what it may do is keep lower-grade prostate cancers from going ballistic.”
 
Hollis notes that the dosage of vitamin D administered in the study — 4,000 U — is well below the 10,000–20,000 U that the human body can make from daily sun exposure. “We’re treating these guys with normal body levels of vitamin D,” he said. “We haven’t even moved into the pharmacological levels yet.”
 
The researchers acknowledge funding from Gateway for Cancer Research, the Department of Veterans Affairs, National Institutes of Health and South Carolina Clinical and Translational Research Institute.
 
The American Chemical Society is a nonprofit organization chartered by the U.S. Congress. 

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Nexafed extended release found bioequivalent to Sudafed 12-hour tablets

BY Michael Johnsen

PALATINE, Ill. — Acura Pharmaceuticals on Monday announced preliminary results from a pilot clinical study which demonstrated bioequivalence of one formulation of Nexafed extended-release tablets to Sudafed 12-hour tablets. Nexafed extended-release tablets utilize Acura's Impede 2.0 enhanced methamphetamine-resistant technology. Acura intends to request a pre-investigational new drug meeting with the Food and Drug Administration to review this data and discuss a complete development program.
 
"These study results validate our ability to move our Impede technology into extended-release formulations," stated Al Brzeczko, Acura's VP technical affairs. "Demonstrating bioequivalence with one formulation this early in our development process allows us to more rapidly advance to discussions with FDA to determine our full development program for this product."
 
The study was conducted in 12 fasted, healthy subjects and measured the systemic absorption of the active ingredient, pseudoephedrine, from a single dose each of two experimental Nexafed extended-release formulations compared to Sudafed 12-Hour tablets. Nexafed formulation B met FDA's standards for bioequivalence for maximum plasma concentration and extent of absorption. Nexafed formulation A met the bioequivalence criteria for extent of absorption but was low for maximum plasma concentration.
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