FDA approves Depomed’s 1,000 mg Glumetza
MENLO PARK, Calif. Depomed has received approval from the Food and Drug Administration for a 1,000 mg strength of Glumetza tablets. Glumetza is used as an adjunct to diet and exercise to improve glycemic control in adult patients with Type 2 diabetes.
“This approval is good news for patients with Type 2 diabetes who are on metformin therapy and prefer to take fewer tablets per day,” stated Carl Pelzel, president and chief executive officer of Depomed. “The American Diabetes Association guidelines recommend that metformin therapy be titrated to its maximally effective dose, generally regarded as 2,000 mg/day as tolerated. We believe this 1,000 mg dosage form is a great addition to the Glumetza franchise, as we now have two ways for patients to achieve 24-hour glycemic control: the original Glumetza 500 mg tablets, which start out as small, easy-to-swallow tablets that expand once in the stomach, and the new 1,000 mg tablets, which require fewer tablets to hit the target dose. We are working very closely with our commercial supplier, Biovail, to make these tablets commercially available in the United States in the near future.”
Depomed acquired exclusive U.S. rights to the 1,000 mg formulation of Glumetza in December 2005 from Biovail, and has a supply agreement with Biovail related to the formulation. Glumetza had sales of $3.8 million in the third quarter of 2007.
Orion, Sun in patent fight over Stalevo
HELSINKI, Finland Orion has extended a patent suit against Sun Pharmaceuticals, which is challenging the company on its Parkinson’s disease treatment drug Stalevo, according to published reports.
Orion is already suing Sun to prevent it from making a generic version of the drug, which is generically called carbidopa/levodopa. Sun has now amended its application to contain Paragraph IV challenges against three of Orion’s patents covering Stalevo.
The challenges mean Sun is either claiming Orion’s patents are invalid or that it would not be infringing on Orion’s patent rights by making a generic version.
Orion, which is evaluating its legal options together with Novartis, the company which exclusively markets Stalevo in the, said the application review process has only just begun and that generic competition is ‘neither certain nor imminent’.
Forest, Cypress submit application to FDA for fibromyalgia treatment
NEW YORK and SAN DIEGO Forest Laboratories and Cypress Bioscience have recently submitted a drug application to the Food and Drug Administration for milnacipran, a drug for treatment of fibromyalgia syndrome, according to published reports.
The submission includes efficacy data from two Phase III trials involving 2,084 patients, which showed that milnacipran demonstrated improvement compared to a placebo in treating fibromyalgia, the companies said.
Currently, only Pfizer’s Lyrica is approved in the U.S. to treat fibromyalgia, which affects up to 6 million Americans.