Alpharma withdraws NDA for Embeda
BRIDGEWATER, N.J. Alpharma has announced that it has withdrawn its application for its chronic pain opioid drug Embeda with the Food and Drug Administration. The company, though, plans to resubmit a revised application as soon as possible.
The initial application was submitted on Feb. 28 and qualified for a priority review but, certain technical issues around data presentation prevented a complete evaluation by the FDA within the six-month time period permissible for a priority review.
Alpharma continues to anticipate a first quarter 2009 launch following approval.
Embeda was developed by combining an extended release opioid with sequestered naltrexone, which is used to block the euphoric effects of the drug when taken incorrectly. When the Embeda capsule was crushed, chewed or dissolved, which are common approaches abusers use to tamper with the product in order to gain euphoria, the naltrexone was released thereby significantly reducing the euphoric effect of the opioid.
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.