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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-86/
- Published: 2016-08-14T12:00:00.000Z
- Updated: 2026-09-14T21:24:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136514

**AstraZeneca** has reported disappointing results from a Phase 3 trial (SELECT-1) of its MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as second-line treatment in patients with KRAS mutation-positive locally-advanced or metastatic non-small cell lung cancer. “The results showed that the trial did not meet its primary endpoint of progression-free survival (PFS), and selumetinib did not have a significant effect on overall survival (OS),” the company says.

**Allergan** and **ForSight Vision5**, a privately held, clinical-stage biotechnology company focused on eye care, have entered into an agreement under which Allergan will acquire the company for a $95 million upfront payment and a launch milestone payment related to ForSight’s lead development program, a peri-ocular ring designed for extended drug delivery and reducing elevated intraocular pressure (IOP) in glaucoma patients. Allergan says the ring is a preservative-free, non-invasive peri-ocular product that rests on the surface of the eye (under the eyelids) and releases bimatoprost over multiple months to lower elevated IOP in glaucoma and ocular hypertensive patients.  
  
**Boehringer Ingelheim** has begun a global Re-Vecto program for Praxbind (idarucizumab), indicated for patients treated with Pradaxa (dabigatran), when reversal of its anticoagulant effects is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. According to the company, the multi-center Re-Vecto Surveillance Program will collect data on Praxbind usage patterns in a clinical practice setting and will enroll at least 300 patients, and all hospital pharmacies where Praxbind is used are eligible to participate

**AcelRx Pharmaceuticals** says its Phase 3 SAP302 clinical trial of ARX-04 (sufentanil sublingual tablet, 30 mcg) in patients who presented to the emergency room with moderate-to-severe acute pain associated with trauma or injury, met its primary endpoint. The company reports that SAP302 enrolled patients in two cohorts: an initial phase of 40 adults who were administered a single dose of ARX-04; and an extension phase of 36 adults who were eligible to receive up to four doses of ARX-04, given hourly as needed for pain. Results showed that overall the 76 adults experienced a mean pain intensity difference to baseline of 2.9 from a baseline of 8.1, or 35%, on a 0 – 10 numeric rating scale at 60 minutes.

**Acacia Pharma Group** reports positive results from a Phase 3 study of Baremsis (amisulpride injection), a novel dopamine D2/D3 antagonist antiemetic, for treating established post-operative nausea & vomiting (PONV). It says the primary endpoint of the study, which enrolled 568 patients, was the successful resolution of the episode of PONV (no recurrence of vomiting or requirement for further antiemetic rescue) in the 24-hour period after treatment, or a complete response. Acacia says both doses of Baremsis significantly improved the complete response rate when compared to placebo.