News + Font Resize -

Canadian marketing approval for Relistor
Collegeville, Pennsylvania | Friday, April 4, 2008, 08:00 Hrs  [IST]

Wyeth Pharmaceuticals, a division of Wyeth, and Progenics Pharmaceuticals, Inc. has received marketing approval from Health Canada, the Canadian Regulatory Agency, for Relistor (methylnaltrexone bromide injection) for subcutaneous use.

Relistor is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care. Health Canada's decision regarding Relistor marks the first regulatory approval of this novel medication anywhere in the world.

"Health Canada granted a priority review for Relistor, which underscores the important need that exists for an innovative medicine that addresses a serious health condition for which there had been limited medical advancement," says Joseph S Camardo, M.D., senior vice president, Global Medical Affairs, Wyeth Pharmaceuticals. "Wyeth and Progenics are pleased to bring Relisztor to patients as an example of our commitment to discover, develop and deliver important new medicines that work in novel ways to benefit patients who need them".

Relistor is the first approved therapy in a new class of drugs designed to relieve one of the significant side effects of opioids on the gastrointestinal tract without interfering with their ability to provide pain relief. When patient response to laxatives has been insufficient, Relistor should be used as an adjunct therapy to induce a prompt bowel movement. Wyeth expects that this product will be launched and available to patients in Canada within approximately 60 days.

"Progenics is proud to share this achievement with the Wyeth team, who have been instrumental in advancing this important new product to market," said Paul J. Maddon, M.D., Ph.D., founder, chief executive officer and chief science officer, Progenics Pharmaceuticals, Inc. "We now await a decision from the US Food and Drug Administration by the end of April on Relistor. In addition, we and Wyeth continue to work with the European and Australian regulatory authorities to expand the availability of Relistor".

Post Your Comment

 

Enquiry Form