A low-dose version of Somerset Pharmaceuticals Emsam (selegiline) patch for the treatment of depression got an important lift from a US Food and Drug Administration advisory committee yesterday, when it was deemed safe for use without a warning label.

The patch, currently under review by the FDA, will be the first antidepressant delivered across the skin if it wins approval. But Somerset has been concerned that the addition of a warning label on Emsam could hold back its market potential.

The FDA said in documents released ahead of the advisory committee meeting that all versions of the patch – 20mg, 30mg and 40mg – should carry a warning about consumption of foods rich in tyramine, an amino acid found in dairy and meat products. All drugs products based on selegiline, a monoamine oxidase inhibitor, carry dietary warnings because if patients ingest too much tyramine while taking them they can suffer dramatic elevations in blood pressure.

But the panel voted by seven to four that Somerset’s clinical data on the 20mg dose of Emsam was robust enough to make the warning unnecessary.

Somerset, a joint venture between Mylan Laboratories and Watson Pharmaceuticals, has always expected the higher doses of the patch to carry a warning, but believes at the lower dose it is not needed. Last February the FDA said that all three doses of the product were ‘approvable’, but asked for additional information on the tyramine issue before it would grant full approval.

The panel also voted that it would not be confusing to have the warning on two strengths of the patch, but not a third.