A Medical Device Daily

The FDA has approved Emsam (selegiline), the first transdermal patch for use in treating major depression. The once-a-day patch works by delivering selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream. At its lowest strength, Emsam can be used without the dietary restrictions that are needed for all oral MAO inhibitors that are approved for treating major depression.

“Emsam provides a significant advance because at least in its lowest dose patients can use the drug without the usual dietary restrictions associated with these types of drugs known as MAO inhibitors,“ said Dr. Steven Galson, director for the FDA’s Center for Drug Evaluation and Research.

Emsam was developed by Somerset Pharmaceuticals (Corona, California). In December 2004, Bristol-Myers Squibb (Princeton, New Jersey) and Somerset entered into an agreement that provides Bristol-Myers Squibb with distribution rights to market Emsam after approval in the U.S. Selegiline was initially approved in capsule form for use in Parkinson’s disease.

MAO inhibitors usually require specific dietary restrictions because when combined with certain foods they can cause a sudden, large increase in blood pressure, or “hypertensive crisis.” The lowest dose of the MAOI patch, which delivers 6 mg of the medication over a 24-hour period, can be used without such dietary restrictions.

The Emsam patch will be made available in three sizes that deliver 6 mg, 9 mg or 12 mg of selegiline per 24 hours. The patch is a matrix containing three layers consisting of a backing, an adhesive drug layer and a release liner that is placed against the skin.

Emsam has been shown safe and effective for treatment of major depressive disorders in two six- to eight-week studies and also in a longer-term study of patients.

Product Briefs

• pSivida (Boston) reported the publication of preliminary three-year follow-up data from Bausch and Lomb’s (B&L; Rochester, New York) multi-center, randomized, controlled clinical trial of Retisert for the treatment of diabetic macular edema (DME). B&L, exclusive licensee of Retisert from pSivida, conducted the study in hospitals in the U.S. in which 197 patients were randomized to receive either standard of care (repeat laser or observation) or a Retisert implant. The study concluded that significantly more patients receiving a Retisert implant had improved visual acuity than those receiving standard of care. Retisert for DME is surgically implanted into the eye and releases a constant amount of the drug, fluocinolone acetonide. Retisert is FDA approved for the treatment of posterior uveitis with a duration of 30 months and is licensed to Bausch & Lomb and co-promoted by Novartis. More data will be presented at the Association for Research in Vision and Ophthalmology conference in May.

• Sorin Group (Milan, Italy), Europe’s largest cardiovascular device company, presented at the JIM congress in Rome the first six-month clinical results from its e-Janus international “real-world” registry. The company said the data confirm that the Janus tacrolimus-eluting Carbostent provides excellent safety profile and clinical efficacy for the treatment of real-world patients, including the high-risk AMI (acute myocardial infarction) patient population. While still recruiting, the e-Janus registry has currently enrolled more than 2,500 patients at more than 80 centers worldwide. Six-month clinical follow-up on 587 patients showed reported a 4.3% major adverse cardiac event (MACE) rate and a 3.1% target lesion revascularization (TLR) rate. Results achieved in the AMI subset of 133 patients included a 3% MACE rate at six-month follow-up, and a TLR rate of 2.2%. The late stent thrombosis rate for this high-risk subgroup was 0%, which the company said demonstrates the excellent safety profile on the thromboresistant Janus platform.

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