In the Pipeline
Access Pharmaceuticals Inc. has completed a 400-patient study and the initial results of that trial evaluating OraDisc, the new formulation of amlexanox in a polymer disc that adheres to the disease site in the treatment of established canker sores. OraDisc achieved statistical significance over both placebo and no treatment by accelerating healing to Day 5 (the primary clinical endpoint).
Bristol-Myers Squibb reports disappointing results from the first of two Phase III trials for its neuroprotective agent BMS-204352 (MaxiPost). The investigational potassium channel agonist showed no significant benefit over placebo for efficacy, safety, or tolerability. A second Phase III trial is scheduled for completion by the middle of 2001, at which time the company says it will have more information about the product.
Millenium Pharmaceuticals has begun a Phase II trial of LDP-02 for ulcerative colitis. LDP-02 is a humanized monoclonal antibody under investigation for the treatment of inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease.
Clinical studies of Pfizer’s non-nucleoside reverse transcriptase inhibitor capravirine (formerly AG1549) have been stopped due to toxicity issues (specifically vasculitis in animals). This is expected to delay possible entry of the drug by more than a year.
New FDA Approvals
Antifungal caspofungin acetate (Cancidas) for injection by Merck & Co. Caspofungin, an echinocandin or glucan synthesis inhibitor, is an antifungal for the treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies (i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole).
Snakebite treatment crotalidae polyvalent immune fabovine (CroFab) by Savage Laboratories. CroFab has been approved for management of patients with minimal or moderate North American crotalid envenomation. It is a safe option for victims of venomous snakebites from most crotalids (including rattlesnakes, cottonmouths, copperheads, and water moccasins). CroFab should be administered by IV as soon as possible (within six hours) following a poisonous snakebite in patients who develop signs of progressive envenomation.
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