ARTICLE | Clinical News

Sublingual TNX-102: Additional Phase IIb/III data

July 13, 2015 7:00 AM UTC

Additional data from the Phase IIb portion of the double-blind, U.S. Phase IIb/III BESTFIT trial in 205 fibromyalgia patients showed that 2.8 mg TNX-102 SL given once daily at bedtime reduced mean average daily pain intensity as measured by the 11-point NRS, the primary endpoint, by 1.5 points from baseline to week 12 vs. 0.97 points for placebo (p=0.086). A significantly greater proportion of patients receiving TNX-102 SL achieved a >=30% improvement in average daily pain intensity from baseline to week 12 vs. placebo (34% vs. 20%, p=0.033). Additionally, TNX-102 SL reduced pain reported during clinic visits, as measured by the 7-day recall NRS, by 1.65 points vs. 0.96 points for placebo (p=0.033) and reduced FIQ-R pain item score by 1.8 points vs. 0.72 points for placebo (p=0.004). TNX-102 SL also improved sleep quality compared to placebo as measured by the PROMIS sleep instrument (p=0.004), the daily sleep diary (p<0.001) and the FIQ-R sleep item (p<0.001). Furthermore, TNX-102 SL led to a PGIC response rate of 30.1% at week 12 vs. 16.7% for placebo (p=0.025). TNX-102 SL reduced FIQ-R total score by 15.6 points from baseline to week 12 vs. 9.1 points for placebo (p=0.014). Data were presented at the European League Against Rheumatism meeting in Rome. ...