Vimovo Demonstrates Benefit Over Naproxen Yesterday, at the American College of Gastroenterology meeting in San Diego, Pozen (POZN) released data from two phase III trials comparing Vimovo (formerly PN400) to enteric-coasted naproxen (ECN) in patients with osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) who are at risk of developing NSAID-associated gastric ulcers. The data demonstrated that patients taking Vimovo experienced significantly greater reduction in severity of dyspepsia (SODA) and overall treatment evaluation for dyspepsia (OTE-DP) compared to patients taking ECN. The OTE-DP results showed 43-46% of the patients on Vimovo reporting positive change at month six vs. only 28-34% on ECN. The results were highly statistically significant. Plus, patients taking Vimovo also had discontinuation rates far below ECN, at 3-5% vs. 11-12%, respectively. The safety of Vimovo was also superior to ECN, with only 2% of the patients experiencing erosive duodenitis as compared to 10-14% for ...

Results from Arena’s (ARNA) phase III BLOSSOM study are strikingly similar to the BLOOM study, with mean total weight loss for the 10mg lorcaserin BID group coming in at 17.0 lbs in BLOSSOM vs. 17.9 lbs in BLOOM. These equated to 7.9% and 8.2% mean absolute weight loss. The placebo was 3.9% and 3.4% in each trial, respectively, putting the mean placebo-adjusted weight loss for each trial at 4.0% and 4.8%. Total categorical weight loss for the completer analysis was 63.2% in BLOSSOM and 66.4% in BLOOM, vs. 34.9% and 32.1% for the placebo. Per the FDA draft guidance: “A product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose ...