The U.S. Food and Drug Administration has asked drug developer Salix Pharmaceuticals for more clinical data on its constipation treatment, Relistor.
The Raleigh, N.C., company said after the markets closed that it had received a letter from the Food and Drug Administration for the additional data. Salix and Progenics Pharmaceuticals Inc. plan to meet with regulators to discuss the letter.
They released no other details about the FDA response.
Progenics licensed rights for the opioid-induced constipation treatment Relistor to Salix Pharmaceuticals Ltd., and the injectable drug is currently approved for use in patients with advanced illnesses who are receiving palliative care. The companies are asking regulators to expand its use to adults with chronic pain not caused by cancer.
They had said in April that the FDA was delaying its decision on the drug until July 27.
Credit Suisse analyst Michael Faerm said in a research note regulators may require more clinical studies, and this decision may have implications for an oral form of the drug under development.
Date: July 30, 2012
Source: Associated Press
Filed Under: Drug Discovery
