Cubist announces results from CB-5945 Phase 2 studies on chronic non-cancer pain, OIC

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that the results from the Phase 2 studies of CB-5945 (formerly ADL5945) in patients with chronic non-cancer pain and opioid-induced constipation (OIC) will be presented at the 31^st Annual Scientific Meeting of the American Pain Society taking place May 16 to 19, 2012, in Honolulu and during Digestive Disease Week 2012 taking place May 19 to 22, 2012, in San Diego.    

Studies 242 (twice-daily dosing; 0.1mg, 0.25mg) and 243 (once-daily dosing; 0.25mg) each met the primary endpoint of change from baseline in the number of spontaneous bowel movements (SBMs) over a four-week treatment period. Of all doses and dosing regimens studied, twice-daily dosing of CB-5945 (0.25mg) was associated with the greatest change from baseline in SBM frequency; 3.42 (P = 0.0003). Moreover, there was a 30% increase in the proportion of overall SBM responders defined as ≥ 3 SBMs/week and an increase of at least 1 SBM/week from baseline for 3 of 4 weeks (26% placebo, 56% 0.25mg BID; P=0.005). In these studies, the incidence of treatment emergent adverse events (TEAE) was comparable between CB-5945 and placebo, with no evidence of reversal of opioid analgesia. The most frequently reported TEAEs were upper respiratory tract infection (study 242: placebo, 14%; 0.1mg BID, 7%; 0.25mg BID, 7%) and upper abdominal pain (study 243: placebo, 7%; 0.25mg QD, 5%).

Source: Cubist Pharmaceuticals, Inc.