Sciele Pharma, Addrenex report successful phase III study on ADHD drug
ATLANTA A phase III clinical study to investigate use of the drug Clonicel for treating attention deficit hyperactivity disorder has shown statistically significant results compared to the placebo, the drug’s makers announced Wednesday.
Sciele Pharma and Addrenex Pharmaceuticals conducted the study on 228 children aged 6 to 17 diagnosed with ADHD, giving them either a placebo or two daily 0.2 mg or 0.4 mg doses of Clonicel for eight weeks. Harmful side effects were mild to moderate in severity, but no serious side effects were reported.
Sciele and Addrenex plan to publish the results at an upcoming medical conference.
“We are pleased to announce the positive results for the phase III trial investigating the use of Clonicel to treat ADHD,” said Sciele chief medical officer Larry Dillaha.
Clonicel, known generically as clonidine, is approved for treating hypertension.
Glue-like bacterial sugar could lead to vaccine
LONDON A study has found that when manipulated with chemicals, a sugar that drug-resistant bacteria secrete triggered an immune response in animals.
The study, presented last week at the Dublin, Ireland, meeting of the Society for General Microbiology used a glue-like sugar that bacteria produce to protect themselves from antibiotics called PNAG.
PNAG alone does not produce an immune response in most people and animals, but the researchers, from the Harvard Medical School, hope that formulations of it do.
FDA announces likely delay on Novo Nordisk diabetes drug
WASHINGTON The Food and Drug Administration has announced that it will be unable to meet the user fee deadline for a timely approval of Novo Nordisk’s drug liragludite.
The FDA will not be able to make an approvability decision until March 23 for the drug, a treatment for Type 2 diabetes. Novo Nordisk had submitted an approval application for the drug on May 23.
The standard review period for FDA action on approval applications is 10 months. Because the agency’s advisory committee meeting will take place shortly before March 23, however, its decision will probably be delayed by a further two months, the company said.