Canker Sores

February 26, 2018

Celgene announced that data from the Phase III RELIEF clinical trial of OTEZLA (apremilast) in patients with active Behçet’s Disease with oral ulcers showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily (BID) versus placebo through week 12. OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4). The RELIEF study is a Phase III randomized, placebo-controlled, double-blind study evaluating apremilast 30 mg BID in 207 patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication. This 52-week study was conducted at 63 sites across ten countries. In the study, a total of 207 patients were randomized to apremilast 30 mg BID or placebo. At week 12, the area under the curve (AUC) for the number of oral ulcers was statistically significantly reduced with apremilast 30 mg BID versus placebo (129.5 vs. 222.1; P<0.0001), the trial’s primary endpoint. The most common adverse events observed in the trial were diarrhea (41.3 percent with apremilast, 19.4 percent for placebo), nausea (19.2 percent with apremilast, 10.7 percent for placebo), headache (14.4 percent for apremilast, 9.7 percent for placebo) and upper respiratory tract infection (11.5 percent for apremilast, 4.9 percent for placebo). This study primarily evaluated the effect of apremilast on recurring oral ulcers in patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication.

June 9, 2003

Access Pharmaceuticals reported positive results from a phase III trial investigating OraDisc A, drug releasing patch for the treatment of canker sores. Results demonstrated a statistically significant enhancement in the primary clinical endpoint, complete healing by day five. The randomized, placebo controlled study enrolled 604 subjects who were divided into three groups. In total, 303 subjects were treated with OraDisc A, which contains the active ingredient amlexanox, 301 subjects received a placebo disc and 97 subjects received no treatment. The full statistical analysis of this study has not been completed. The company plans to file for approval in the U.S. and Europe in the coming months.

InterMune reported positive interim data from a phase IV trial investigating Infergen (interferon alfacon-1) for the treatment of chronic hepatitis C infection. Results demonstrated that more than half (52%) of the subjects have responded to the treatment. At week 8, an antiviral response in serum was observed in 20% (6/30) and 27% (8/30) of subjects treated with the daily dosing and induction dosing regimen, respectively. At week 24, an antiviral response was observed in 40% (10/25) and 52% (14/25). Both the daily dosing and induction dosing regimens were found safe and moderately well tolerated. Adverse events included myalgia, fatigue and headache. The randomized, open-label trial was conducted in 50 chronic hepatitis C subjects who were non-responders to prior combination therapy with pegylated interferon and ribavirin. The trial will continue with combination therapy for an additional 24 to 64 weeks. Results were reported at the Digestive Disease Week 2003 conference in Orlando, Florida.