New COPD drug under review

Sunday, August 20, 2006

MARLBOROUGH, Mass. - A new COPD drug could be a shot in the arm for the beleaguered inhalation drug market. Arformoterol tartrate, a long-acting bronchodilator developed by Xopenex-maker Sepracor is currently under review by the Food and Drug Administration.

If approved, it would be the first new nebulizer drug to hit the market in several years, said Mickey Letson, president of Decatur, Ala.-based Letco.

While dosing specifics have yet to be released, Sepracor confirmed that arformoterol is indicated for twice daily treatment. Compared to the standard four times-day treatments currently available, arformoterol has the potential to improve patient compliance, said Letson.

"With this product, the patient can take it in the morning and before bed," said Letson. "A patient can get up and go about their day without taking their MDIs or travel nebulizers with them."

While most industry watchers don't expect arformoterol to meet FDA resistance, Medicare approval for reimbursement is another matter. But with Sepracor behind the drug, it has a chance, said Chris Lemley, president of JCL Medical in Decatur, Ala.

"If they get it priced right and if they get a code, it's definitely good for the market," said Lemley. "But the manufacturers have proven they can lobby for things and get them."

CMS could downgrade the new drug to generic formoterol which has a HCPC code but is not favored by CMS's pricing structure, said Wayne Vega, a consultant to Stat Vial in New Iberia, La.

"On reimbursement, CMS, and more importantly, the DMERCs, have done everything they could in the last 20 years to impede us," said Vega. "So if it gets the same HCPC code as formoterol, and not its own, it will not be a successful product or available to the patient population or market."