"Dimethaid Research Inc - In the News
Globe says Dimethaid's FDA secret disclosed
The Globe and Mail reports in its Friday, Oct. 8, edition that after two years of silence, Dimethaid Research has disclosed that United States regulators in August, 2002, asked the firm to conduct additional late-stage clinical studies of its topical Pennsaid pain reliever. The Globe's Leonard Zehr writes that the disclosure by the new board of directors, which took control of Dimethaid last month, differs markedly from statements made by the company during the recent proxy battle about the drug's status at the U.S. Food and Drug Administration. In a letter to shareholders Thursday, Dimethaid said it began enrolling patients last March in two phase III studies to test the long-term safety of the lotion and its efficacy against a pain pill "in accordance with the FDA's suggested design." The trials are scheduled for completion at the end of 2005, with a filing to the FDA by mid-2006 and possible approval by early 2007. Dimethaid originally filed for FDA approval of Pennsaid in March, 1998, but has failed to give any reasons for the protracted review. It did not disclose earlier concerns raised by the FDA, which forced the company to start a new set of trials in March." |
