August 2007
Medicine for Postoperative Bunion Pain
Posted 8/22/07
A Phase III trial for oxycodone HCl and niacin (OxyADF) tablets is set to enroll participants. The opiod pain reliever will be tested as treatment for acute, moderate-to-severe postoperative pain following bunionectomy surgery. The three-arm clinical trial will compare two dose levels of OxyADF tablets with placebo. Medication will be administered to patients every six hours for 48 hours following pain onset. The trial is targeted to enroll 135 patients per arm.
Treatment for Dupuytren’s Contracture
Posted 8/20/07
The FDA has given clearance for the continuation of Phase III clinical trials for Xiaflex (clostridial collagenase for injection) for the treatment of Dupuytren’s contracture. Dupuytre’s contracture is a condition that impairs a person’s ability to straighten and move their fingers due to a thickening and shortening of ligaments of the palm and fingers.
Pain Reliever for Chronic Conditions
Posted 8/20/07
Positive results from a 12-week, Phase III clinical trial of fentanyl buccal (Fentora) was announced for patients with breakthrough pain associated with a broad range of chronic noncancer conditions. The 148-patient, double-blind, placebo-controlled, variable dose Phase III trial had a primary endpoint of the sum of pain intensity differences from five to 60 minutes as assessed after 12 weeks of treatment. According to the study, patients treated with Fentora showed a statistically significant improvement compared with placebo.
Anti-Inflammatory Granted Priority Review
Posted 8/14/07
The FDA has granted priority review status to the biologics license application for rilonacept for the long-term treatment of cryopyrin-associated periodic syndromes (CAPS). The FDA is expected to take action on the application by the end of November. Currently, there are no medicines approved for CAPS, a spectrum of rare inherited inflammatory conditions, including familial cold autoinflammatory syndrome and Muckle-Wells Syndrome.
Oral Calcitonin Clinical Study
Posted 8/14/07
Currently offered as a nasal spray, an oral calcitonin formulation for the treatment of osteoporosis has gone to clinical trial. The tablets used in the study utilize an improved solid dosage form. The novel dosage form is the subject of a recently filed patent application and has already been shown in animal studies to deliver a more consistent dose of calcitonin while maintaining therapeutic blood levels of this peptide.
