Pharmaxis announces completion of phase 3 trial for CF drug
SYDNEY, Australia An Australian company announced Tuesday that it had finished the first part of an international phase 3 trial of a drug for cystic fibrosis.
Pharmaxis said the final patient in the trial of the inhaled drug Bronchitol (mannitol) had finished a final clinical visit, and the trial was running on time and on budget. Results of the trial are expected to be available later this month.
“We are very pleased to announce this major milestone for Pharmaxis and look forward to the results of the study with great interest,” Pharmaxis CEO Alan Robertson said. “It is hoped that Bronchitol will change the therapeutic landscape for people living with cystic fibrosis and provide a new therapeutic regimen that helps to prolong life.”
A second phase 3 clinical trial is recruiting in the United States, Canada, Argentina, Germany, Belgium and France, Pharmaxis said. The Food and Drug Administration and European Medicines Agency have given Bronchitol orphan drug designation due to the lack of effective treatments for cystic fibrosis.
Study: Anti-smoking medication effective treatment for patients with cardiovascular disease
ORLANDO, Fla. An anti-smoking drug normally prescribed to otherwise healthy people also works for people with cardiovascular disease, according to a study.
Study results presented Tuesday at the American College of Cardiology’s 58th Annual Scientific Session indicate that 47% of smokers with a history of cardiovascular disease who take Pfizer’s drug Chantix (varenicline) were able to quit without relapse for the first four weeks of treatment, compared to 13.9% who received placebo.
“These data are consistent with the findings from the pivotal varenicline trials, which showed that varenicline was more effective than placebo among smokers who were generally healthy,” lead study investigator, Harvard Medical School professor of medicine and director of the Tobacco Research and Treatment Center at Massachusetts General Hospital Nancy Rigotti stated. “This study demonstrates that varenicline is effective in helping smokers with cardiovascular disease quit smoking.”
Approximately 130,000 people die each year from smoking-related cardiovascular disease in the United States, constituting about one-third of all smoking-related deaths among adults aged 35 and older.
FDA approves vaccine for Japanese encephalitis
ROCKVILLE, Md. A viral disease mostly found in Asia but rare in the United States that kills as many as 15,000 people a year now has a vaccine.
The Food and Drug Administration approved British drug maker Intercell Biomedical’s Ixiaro, a vaccine for Japanese encephalitis. The mosquito-borne disease, which affects between 30,000 and 50,000 people each year, is sometimes found among civilians and military traveling between the United States and Asia.
Symptoms of JE include flu-like symptoms that can progress to high fever, neck stiffness, brain damage, coma and death.