MANSFIELD – Covidien Plc has begun selling Exalgo extended-release tablets following some delays in the U.S. Food and Drug Administration’s approval process.
Exalgo (hydromorphone HCI) is intended as a treatment for patients with moderate to severe chronic pain. According to Covidien, Exalgo is the only extended-release hydromorphone treatment available in the United States, and is being sold in 8 milligram, 12 mg and 16 mg tablets.
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“Covidien is focused on providing patients with access to advanced medications that expand the limits of pain therapy by combining proven drugs with innovative delivery systems,” said Timothy R. Wright, Covidien’s president for pharmaceuticals. The company also launched a program to help ensure the drug is used safely.
Approval for the drug was postponed in November after the FDA requested additional information on it. In late February, the FDA had to postpone its review by another week due to the heavy snowstorms that shut down most of Washington, D.C. The drug was officially approved on March 1.
Covidien paid $10 million last June to get the U.S. commercialization rights to Exalgo from Neuromed Pharmaceuticals Ltd. The agreement said Covidien would pay up to $73 million to Neurmoed and Alza Corp., the drug’s original developer, if Exalgo is successfully approved and sold.
Neuromed was acquired by Cambridge, Mass.-based CombinatoRx Inc. late last year.
The release of Exalgo followed a serious setback suffered by Covidien recently. The company was forced to recall breathing tubes on April 24 after it was reported that three people died while using the tubes.
The tracheostomy tubes are placed in patients’ throats to help them breathe through ventilators. Covidien reported receiving roughly 1,200 complaints about the Shiley-branded cuffed tubes malfunctioning. The FDA is now investigating the matter.
