Joiner launches Madeira to focus on pediatric dosages
LEAWOOD, Kan. Peter Joiner, a veteran of the pharmaceutical industry for over 30 years, this week announced the launch of a new company called Madeira Therapeutics, of which he will be the chief executive officer.
The company will focus on repositioning approved adult compounds for use in the pediatric market. “More than 70 percent of the drugs prescribed for children are not approved by the Food and Drug Administration,” Joiner said. “The current approach is to prescribe adult drugs by weight; however, children metabolize some drugs differently than adults so this not in the best interest of the patient.”
The company will use a rule that the FDA has developed that will allow them to re-formulate off patent adult drugs because the drugs have already been shown to be safe and effective. By using this method, the company does not need to conduct large clinical trials in order to get its drugs approved.
In addition to a cholesterol drug already in the pipeline, Madeira has plans to develop pediatric formulations for acute pain management and diabetes.
FDA approves first U.S. drug for IBS-C
WASHINGTON Takeda and Sucampo Pharmaceuticals’ Amitiza, indicated for treatment of irritable bowel syndrome with constipation, was approved by the Food and Drug Administration for women over the age of 18, according to published reports.
IBS, an ailment characterized by cramping, abdominal pain, bloating, constipation and diarrhea, affects twice as many women as men, the FDA said. The reason for Amitiza’s approval for women only, however, was based on a lack of proof that the drug was effective for men.
“For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities,” said Julie Beitz of the FDA’s Center for Drug Evaluation and Research. “This drug represents an important step in helping to provide medical relief from their symptoms.”
Amitiza (lubiprostone) is already approved for the treatment of chronic idiopathic constipation, though at a much higher dosage than for treatment of IBS-C.
CDC says more than 25% of children not receiving recommended vaccinations
WASHINGTON According to the Centers for Disease Control and Prevention, more than a quarter of children in the U.S. are not meeting childhood vaccinations in accordance with government recommendation, according to Reuters. The study was of children between the ages of 18 months and 3-years-old.
The report went beyond studying if children were getting the recommended number of doses of various vaccines by, examining whether the children were getting them at the right time.
CDC researchers found that 28 percent did not meet vaccination recommendations. The results were based on a 2005 government survey involving 17,563 U.S. children in that age group.
Missed doses accounted for about two-thirds of those not in compliance. The rest of the children got them at the wrong age or too soon after a previous dose to be considered completely effective. Using the usual method of examining only whether children got the right number of doses, 81 percent of the children met government recommendations, according to the CDC.
The CDC recommends a number of vaccines to protect children against diseases like measles, polio, mumps, chicken pox and several others. Some require multiple doses.