Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that it presented information to members of a U.S. Food and Drug Administration (FDA) Advisory Committee on the New Drug Application and proposed Risk Evaluation and Mitigation Strategy (REMS) program for EXALGOTM (hydromorphone HCl extended release) tablets, an opioid formulation. At a meeting held today in Gaithersburg, Md., committee members also heard public comments about the analgesic. Covidien will now await FDA’s decision on EXALGO approval.
“We are pleased that the committee endorsed the REMS program as proposed by Covidien and Neuromed,” said Timothy R. Wright, President, Pharmaceuticals, Covidien. “The committee has asked us to look at the possibility of a phased rollout, and we look forward to discussing this input with the agency and other pain management experts.”
If approved, EXALGO will offer around-the-clock relief for opioid tolerant patients with moderate to severe pain for an extended period of time. EXALGO utilizes a unique, extended-release technology that allows for once-a-day dosing. This technology is the OROS® Push-Pull™ oral osmotic delivery system that is designed to release the hydromorphone at a consistent rate. This proven technology has been used for 20 years in 13 other products. For physicians, EXALGO provides a well-known therapy used in the treatment of chronic pain for more than 80 years – hydromorphone HCl, in an extended-release formulation.
During the meeting, information was provided on Exalgo Alliance – the proposed REMS for EXALGO, which is a comprehensive program that combines education, controlled access and ongoing surveillance. Combined with EXALGO’s proposed labeling, Exalgo Alliance will help ensure the appropriate access, prescribing, dispensing and use of EXALGO.