Favorable adverse event profile of tedizolid phosphate compared to linezolid in a phase 3 ABSSSI study

Purpose: Tedizolid phosphate is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Adverse events reported in a phase 3 ABSSSI study comparing 6 days of oral tedizolid phosphate 200 mg qd (followed by 4 days of placebo) with 10 days of oral linezolid 600 mg bid were reviewed.

Methods: A total of 666 adult subjects with ABSSSI were randomized to tedizolid phosphate or linezolid therapy and received at least one dose of study drug. Treatment-emergent adverse events (TEAEs) by System Organ Class (SOC) and Preferred Terms (PT), Investigator-determined relationships and serious adverse events (SAEs) were reviewed. Coding was performed with MedDRA version 13.1.

Results: Overall, TEAEs frequencies were similar in the tedizolid phosphate and linezolid treatment arms, 40.8% and 43.3%, respectively, though rates of Investigator-determined drug-related TEAEs were lower for tedizolid phosphate compared with linezolid, 24.2% and 31.0%, respectively. Rates of TEAEs leading to discontinuation of study drug were 0.6% in both groups, and rates of SAEs were 1.5% and 1.2%, respectively. Most TEAEs in both treatment groups were mild, with similar distribution of severity. 

Conclusion: Overall, subjects receiving tedizolid phosphate and linezolid in this phase 3 ABSSSI trial had similar rates of TEAEs, SAEs, and discontinuation of study drug due to TEAEs. However, there were more Investigator-determined drug-related TEAEs in the linezolid group. Additionally, subjects receiving tedizolid phosphate had significantly better GI tolerability compared with linezolid.