Below is a summary of updates to the
BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of
BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
On 6/16/09, shares of Matrixx Initiatives (NASDAQ:MTXX) were plunging after the FDA ordered the Company to stop selling zinc-containing, intranasal versions of its Zicam cold remedy after more than 130 reports of people losing their sense of smell. The FDA also urged consumers to stop taking the over-the-counter products, according to Agency officials on a conference call with reporters. MTXX must seek FDA approval if it wants to continue selling the zinc-containing versions of Zicam that are administered through the nose, agency officials said.
On 6/16/09, ARYx Therapeutics (NASDAQ:ARYX) announced that the database for the EmbraceAC study has been locked and the study remains on schedule, with the efficacy and safety results to be available during the week of 7/6/09. The study was designed to compare its oral anticoagulation therapy, tecarfarin (previously ATI-5923), against the leading anticoagulant agent, warfarin. The purpose of the trial is to evaluate whether tecarfarin is superior to warfarin in its ability to maintain patients within a target therapeutic range of the level of anticoagulation as measured by INR (International Normalized Ratio). Based upon recent interactions with the FDA, ARYX believes this trial could be positioned as one of the required registration studies for tecarfarin.
The trial of approximately 600 patients is a randomized, double blind, parallel group, active control study comparing tecarfarin with warfarin in patients who require chronic, oral anticoagulation. All patients in the study were treated for a minimum of six months and required anticoagulation therapy to avoid serious blood clotting resulting from their underlying condition. Tecarfarin (previously ATI-5923) is modeled on the drug warfarin as an oral blood thinner, which works in the same way (as a selective inhibitor of VKOR or the vitamin K epoxide reductase enzyme). Unlike warfarin, which is dependent upon cytochrome P450 enzymes for metabolism, tecarfarin was designed to avoid drug-drug interactions through its alternative metabolic pathway.
