Mass. health regulators seek to curb Rx abuse
BOSTON Prescription drug abusers who go “doctor shopping” in search of prescriptions will face a new challenge in Massachusetts, according to published reports.
The Boston Globe reported that health regulators in the state have approved a system that will allow pharmacists and physicians to check names of patients against those in an online database to see if they have filled prescriptions for drugs that can be abused.
According to the newspaper, Massachusetts had more than 600 deaths related to drug abuse last year, and abuse of prescription painkillers has become about as common as that of illegal drugs.
Curemark gets nod to start late-stage trial for ADHD drug
RYE, N.Y. The Food and Drug Administration has approved a late-stage clinical trial of a drug for attention deficit hyperactivity disorder.
Curemark said the FDA cleared its application to run a phase 3 trial of CM-4612 in patients with ADHD. The company is currently conducting a phase 3 trial of CM-AT, a treatment for autism in children.
“We are very excited to have received [clearance] from the FDA so that we can move forward with clinical trials to study CM-4612,” Curemark CEO Joan Fallon said. “Curemark hopes to have the first physiologically based medication to address ADHD, in lieu of the current psychotropic and stimulant treatments.”
FDA approves additional dosage for NovoSeven RT
PRINCETON, N.J. The Food and Drug Administration has approved a new dose of a treatment for hemophilia from Novo Nordisk, the Danish drug maker said.
The FDA approved Novo Nordisk’s NovoSeven RT (coagulation factor VIIa [recombinant], room temperature stable) in 8-mg vials. The treatment, which comes in the form of a powder mixed for injection, was already available in 1, 2 and 5 mg vials. The FDA also approved an extension of shelf life for all vial sizes from 24 months to 36 months at or below 77 degrees.
NovoSeven RT is formulated for patients with hemophilia A or B with inhibitors. The new dosage will shorten the time it takes to prepare the injection, known as reconstitution, compared with current dosages.