The U.S. FDA shot down Oxford Pharmascience Group PLC's proposed phase 3 study design for OXPzero, the company's reformulated version of ibuprofen.
The regulator disagreed with the proposed primary endpoints of the study and asked that the company undertake a clinical trial to back claims of improved gastrointestinal safety. The study would require improvements in peptic ulcer bleeding and related complications to qualify.
Oxford could skip a clinical study altogether if it tones down the claim for the drug which would not require a detailed trial, the FDA suggested alternatively.
Oxford said it would consider the FDA suggestions carefully before a decision is made on the development program.
The company's stock price was down 32.73% to £2.04 per share as of 11:17 a.m. ET on March 31.