Baudax Bio Announces FDA Approval of ANJESO for the Management of Moderate to Severe Pain - Seite 2

The ANJESO approval is supported by two Phase III efficacy studies and one double-blind, placebo-controlled Phase III safety study.  The results from these studies, as well as results from four Phase II clinical studies and other safety studies, comprised the NDA package.

The most common ADVERSE REACTIONS reported in ≥2% of patients treated with ANJESO and at a greater frequency than placebo included: constipation, gamma-glutamyl transferase increased and anemia.

Please see “News & Investors” section of the Company’s website at www.baudaxbio.com for full Prescribing Information in addition to the full Important Safety Information provided below.

Baudax expects ANJESO will be available in the U.S. in late April or early May 2020.  For more information, visit www.baudaxbio.com.

Conference Call and Webcast

Baudax Bio management will be hosting a conference call and webcast today beginning at 4:30 p.m. ET. To access the conference call, please dial [phone] (local) or [phone] (international) at least 10 minutes prior to the start time and refer to conference ID 4373423.A live audio webcast of the call will be available under "Events" in the Investor section of the Company's website, https://www.baudaxbio.com/news-and-investors/events. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 30 days.

ANJESO COMPREHENSIVE CLINICAL TRIALS

Phase 3  Efficacy Study Evaluating ANJESO Following Bunionectomy Surgery

In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 201 patients were enrolled and randomly assigned to receive a postoperative regimen of ANJESO (30mg) or placebo in a 1:1 ratio, once every 24 hours for up to 3 doses following bunionectomy surgery, a representative hard tissue surgery. The ANJESO treatment arm demonstrated a statistically significant reduction in SPID48 (p=0.0034) compared to the placebo arm. The study also achieved 15 of the 19 secondary endpoints, including statistically significant differences in SPID6 (p=0.0153), SPID12 (p=0.0053), SPID24 (p=0.0084), SPID24-48 (p=0.0050), time to first use of rescue medication (p=0.0076), and several other rescue use and pain relief metrics during the first 48 hours, compared to placebo. The safety results demonstrated that ANJESO was well tolerated with no serious adverse events or bleeding events in the ANJESO-treated patients.