FDA grants regulatory guidance for nail fungus treatment
SAN DIEGO — Drug maker Apricus Biosciences will receive regulatory guidance from the Food and Drug Administration in July that will contain feedback concerning the drug maker’s plans to seek approval for a nail fungus treatment.
Apricus said Tuesday that the FDA granted its request for guidance concerning MycoVa (terbinafine hydrochloride) that will help determine the suitability of the drug’s clinical trial data to support regulatory approval. The drug uses a common treatment for nail fungus, also known as onychomycosis, delivered using the company’s special drug delivery technology.
"This FDA guidance is an integral step in the process of bringing the safe and effective treatment benefits of MycoVa to patients suffering from mild to moderate onychomycosis," Apricus president and CEO Bassam Damaj said. "Extensive clinical trial data and a robust international patent estate firmly support the marketing potential of MycoVa, and we look forward to receiving necessary guidance from the FDA to move the process forward in the U.S."
Study: Flu shots could provide unanticipated benefits to expectant moms
OTTAWA — Getting a flu shot during pregnancy provides unanticipated benefits to the baby, according to the authors of a large population-based study examining the issue. Specifically, the study showed that H1N1 vaccination during the pandemic was associated with a significantly reduced risk of stillbirth, preterm birth and extremely small babies at birth.
Researchers at the Ottawa Hospital Research Institute, the CHEO Research Institute and the University of Ottawa used data from Ontario’s birth record database, BORN, to examine 55,570 single-child births that took place in Ontario during the H1N1 pandemic. The resulting paper, "H1N1 Influenza Vaccination during Pregnancy and Fetal and Neonatal Outcomes," was recently published by the American Journal of Public Health.
The study showed that, compared with pregnant women who were not immunized against H1N1, mothers who received the H1N1 vaccination were:
- 34% less likely to have a stillbirth;
- 28% less likely to deliver before 32 weeks; and
- 19% less likely to give birth to a child with a birth weight for gestational age in the bottom third percentile.
"These are all significant results, but especially interesting is the finding that the vaccinated mothers were one-third less likely to have a stillborn child," stated lead author Deshayne Fell, an epidemiologist for BORN Ontario. "This is one of the only studies large enough to evaluate the association between maternal flu vaccination and stillbirth — a very rare event."
"What surprised me and the research team was the strength of the protective benefits we found," added co-author Ann Sprague, the scientific manager of BORN Ontario at the Children’s Hospital of Eastern Ontario Research Institute.
The study also found no increase in adverse outcomes for H1N1-vaccinated mothers and their babies during the weeks before and just after birth, also referred to as the perinatal period.
"The findings of this study are very helpful," commented co-author Mark Walker, a senior scientist at OHRI, a high-risk obstetrician at the Ottawa Hospital, and a professor and tier one research chair in perinatal research at the University of Ottawa. "Pregnant women are generally very, very careful about what they put into their bodies. For healthcare providers like me, such a large-scale study that shows no adverse perinatal outcomes resulting from the H1N1 flu vaccine will be extremely helpful when discussing maternal vaccination."
Of all the single-child births recorded from November 2009 to April 2010, 42% of the women received the H1N1 vaccination, which makes the findings robust. BORN — the Better Outcomes Registry and Network — collects data from all births in Ontario. In order to conduct the research for this study, questions about H1N1 vaccination were added to the database in advance of the H1N1 vaccine becoming available. BORN includes demographic data that allowed the research team to correct for smoking, education and income; however, as with any population-based study, it may not be possible to account for all influencing factors.
Prevalence of prediabetes, diabetes among adolescents on the rise
NEW YORK — Being overweight and obesity during adolescence are associated with an increased risk for cardiovascular disease risk factors, especially prediabetes and diabetes, according to researchers.
Analyzing data from the National Health and Nutrition Examination Survey, researchers found that among adolescents ages 12 too 19 years, the prevalence of prediabetes/diabetes increased from 9% in the 1999-2000 NHANES to 23% during the 2007-2008 NHANES. While prediabetes/diabetes experienced an increase, the researchers also noted that other CVD risk factors — such as prehypertension/hypertension (17% and 13%) and borderline-high/high low-density lipoprotein cholesterol (23% and 19%) — saw no significant change when observed in the 1999-2000 NHANES and 2007-2008 NHANES.
The results were published in Pediatrics.