Astellas Pharma introduces new formulation of Vaprisol
DEERFIELD, Ill. Astellas Pharma US announced this week the introduction of a new formulation of a drug for treating hyponatremia.
The Tokyo-based drug maker introduced Vaprisol (conivaptan hydrochloride injection) Premixed in 5% Dextrose, a new premixed formulation. The Food and Drug Administration originally approved the drug in October.
“It is imperative to promptly address hyponatremia in emergency and hospital settings,” Georgetown University medicine and physiology professor Joseph Verbalis said in a statement. “Vaprisol Premixed in 5% Dextrose is a convenient option for quickly preparing treatment for hyponatremia patients.”
Hyponatremia is a potentially life-threatening condition that occurs when the body’s blood sodium level falls significantly below normal. It is present in about 28% of patients upon admission into acute hospital care, and another 14% acquire it while in acute care. It can result in swelling of the brain, respiratory arrest, catastrophic brain damage and death.
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.
Court finds that Watson’s ADHD drug patent is valid
CORONA, Calif. The U.S. District Court for the District of Delaware ruled Monday that Watson Pharmaceuticals’ generic version of an ADHD drug does not infringe the branded drug maker’s patent.
Watson announced the court ruling Tuesday, saying judge Joseph Farnan found that the ‘373 patent for Concerta (methylphenidate hydrochloride extended-release tablets), by ALZA Corp. and McNeil-PPC, is invalid. The ruling applies to Watson’s versions of Concerta in the 18 mg, 27 mg, 36 mg and 54 mg strengths.
“We are very pleased that the court has ruled in our favor, and we will continue to evaluate the court’s opinion as we contemplate next steps,” Watson president and CEO Paul Bisaro said. “We are currently pursuing final FDA approval of this important product.”
The two branded companies originally sued Andrx Corp. in 2005 over the drug; Watson acquired Andrx the next year.