FDA Approves Lantus SoloStar(R) - A New Prefilled Disposable Insulin Pen For Use With LANTUS(R) In People With Type 1 And Type 2 Diabetes

Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved Lantus SoloStar(R), a new prefilled disposable insulin pen for once-daily 24- hour insulin LANTUS(R) (insulin glargine) for the treatment of hyperglycemia in people with type 1 or type 2 diabetes. The introduction of Lantus SoloStar(R) offers a convenient option for administering once-daily 24-hour LANTUS(R), the number one prescribed insulin in the world. LANTUS(R) in the Lantus SoloStar(R) pen provides diabetes patients with an alternative to the traditional needle and syringe for insulin therapy. Lantus SoloStar(R) is the only disposable insulin pen that allows patients to administer doses from 1 up to 80 units, in one injection. "Sanofi-aventis is committed to working with the diabetes community to develop new technologies intended to help make the difficult task of managing diabetes simpler and more convenient," explained Gilles Lhernould, Senior Vice President Industrial Affairs, sanofi-aventis. "Lantus SoloStar(R) is the result of more than 4 years of intensive development and testing with diabetes patients, doctors and nurses," he added. Lantus SoloStar(R) is expected to be available in pharmacies in 2007. "Insulin therapy for people with type 2 diabetes is generally initiated very late in the course of the disease, leaving many patients with high blood glucose levels," explained Satish Garg, MD, Chief, Young Adult Clinics, Professor of Pediatrics & Medicine, Barbara Davis Center for Diabetes, University of Colorado School of Medicine, Denver, USA. "Easier delivery devices like disposable pens can make using insulin more convenient." New Lantus SoloStar(R) Test Results Published In a separate but related event, sanofi-aventis also announced today the publication of Lantus SoloStar(R) dose accuracy and injection force test results. These results appear in the March issue of the journal Expert Opinion on Drug Delivery. All testing was performed in a laboratory setting and did not include testing on patients. Dose accuracy testing was conducted according to International Organization for Standardization (ISO) test standards to evaluate whether the Lantus SoloStar(R) pen would repeatedly deliver the dialed dose under a range of conditions. The results demonstrated that Lantus SoloStar(R) accurately and consistently delivered the dialed dose of insulin well within the ISO standard. Injection force testing was performed to measure the force required to dispense a known volume of insulin within a fixed time period compared to other currently marketed insulin pens. The results showed that the Lantus SoloStar(R) pen had a mean total injection force that was more than 30% less than other frequently used disposable pens(1). The full study, "Dose accuracy and injection force dynamics of a novel disposable insulin pen," is available at the Expert Opinion on Drug Discovery Web site:

(Author: http://www.expertopin.com/doi/abs/10.1517/17425247.4.2.165)

<< Prev	Pharmacy News Home	Next>>