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Background: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation in clinical development. A phase 2 dose-ranging study identified an optimal dose and demonstrated efficacy with a median duration of 24 weeks. Methods: In two phase 3, multicenter, randomized, double-blind, placebo-controlled studies (SAKURA 1 and SAKURA 2), subjects with moderate or severe glabellar lines at maximum frown were assigned randomly to receive placebo or 40 U of DAXI. Glabellar lines were evaluated at least every 4 weeks for at least 24 weeks until severity returned to baseline (≤36 weeks). Results: Overall, 609 subjects were enrolled (DAXI, n = 405; placebo, n = 204). DAXI was significantly more effective than placebo in achieving the primary efficacy outcome (≥2-point improvement in glabellar line severity at maximum frown at week 4 according to both investigator and subject ratings): 73.6 percent versus 0.0 percent (SAKURA 1), and 74.0 percent versus 1.0 percent (SAKURA 2) (both p < 0.0001). Composite investigator and subject ratings of maximum frown after DAXI treatment showed that glabellar line severity of none or mild was maintained for a median of 24.0 weeks (SAKURA 1) and 23.9 weeks (SAKURA 2), and glabellar line severity did not return to baseline levels for a median of 27.7 and 26.0 weeks, respectively. DAXI was generally well tolerated, with the most common adverse events related to DAXI treatment being headache (SAKURA 1, 7.0 percent; SAKURA 2, 5.9 percent) and injection-site pain (5.0 percent and 2.4 percent, respectively). Conclusions: Results from both studies were highly consistent. DAXI may offer a prolonged duration of response (median, ≥24 weeks) and is generally well tolerated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Diverticular disease is a common problem where patients with diverticulosis have a 1–4 per cent risk of acute diverticulitis. Current guidelines recommend a colonoscopy after.the resolution of acute diverticulitis. The aim of this study was to evaluate the yield of significant findings on colonoscopy after an episode of diverticulitis. This is a retrospective analysis of patients who underwent colonoscopy after an episode of diverticulitis between November 2005 and August 2017 at three major teaching hospitals. Advanced adenomas were defined as adenomas ≥1 cm, serrated adenomas, and tubulovillous or villous adenomas. A total of 584 patients (298 males; 51%) underwent colonoscopy for a history of diverticulitis after resolution of acute symptoms. Colonoscopy was complete in 488 patients (84%). Among these 488 patients, 446 had diverticular disease, 31 had advanced adenomas, and four had adenocarcinomas. Colonoscopies were incomplete in 96 patients (16%). Forty-six of those patients underwent surgery. The overall incidence of advanced adenomas and adenocarcinomas was 32 (5.4%) and nine (1.5%), respectively. In our study, the prevalence of advanced adenomas and adenocarcinomas was relatively high compared with the average risk individuals. Our findings support that patients after an episode of diverticulitis should continue to get a colonoscopy.