Health & Fitness
Tue, May 15, 2012
LEXINGTON, Mass.--([ BUSINESS WIRE ])--[ 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 31st 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.
"Chronic Pain In America: Roadblocks To Relief."
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 a 3SBMs/week and an increase of at least 1SBM/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%).
About Opioid-Induced Constipation (OIC) and CB-5945
The American Pain Foundation estimates that 9% of the U.S. adult population suffers from moderate to severe non-cancer related chronic pain1, which is commonly defined as pain that lasts longer than the usual course of an injury or illness. Long term management of chronic pain often includes treatment with opioid analgesics. Many people receiving this treatment will develop constipation, as well as other associated gastrointestinal complications. This is believed to be the result of the stimulation of mu opioid receptors in the gastrointestinal tract by opioid analgesics2. The stimulation of these peripheral mu opioid receptors disrupts regulation of motility, secretion and absorption. CB-5945 is a potent, peripherally acting mu opioid receptor antagonist that is designed to block the adverse effects of opioid analgesics on the gastrointestinal tract without compromising the pain relief caused by opioid action in the central nervous system. Currently, there are no FDA-approved therapies to treat OIC in patients with chronic non-cancer pain.
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. Cubist is headquartered in Lexington, Mass. Additional information can be found at Cubistas web site at [ www.cubist.com ].
Cubist Safe Harbor Statement
This press release contains forward-looking statements regarding the clinical development of CB-5945, including plans to run Phase 3 clinical trials for this compound in the treatment of opioid-induced constipation. There are many factors that could cause actual results to differ materially from those in these forward-looking statements. These factors include the following: CB-5945 may not show sufficient therapeutic effect or an acceptable safety profile in Phase 3 clinical trials; CB-5945 may not act in the way expected based on prior clinical and pre-clinical trials; clinical trials of CB-5945 may not be successful or initiated or conducted in a timely manner and the timing of initiation and conduct of subsequent trials is dependent on our ability to successfully work with regulatory authorities, including the FDA on the design of the trials, among other things; we plan to rely, to a significant extent, on third party clinical research organizations, or CROs, to help us conduct clinical trials so the success and timing of the trials is dependent our ability to work with such CROs and their performance; technical difficulties or excessive costs relating to the manufacture or supply of CB-5945; we plan to rely, to a significant extent, on third party contract manufacturers and suppliers to manufacture and supply CB-5945 on our behalf so our ability to obtain adequate supplies of CB-5945 is dependent on our ability to work with such third parties and on their performance; we may not be able to maintain and enforce the intellectual property protecting CB-5945; and we may encounter other unanticipated or unexpected risks with respect to the development or manufacture of CB-5945. Drug development involves a high degree of risk. Success in pre-clinical trials or early stage clinical trials does not mean that later stage trials will be successful. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Cubist's recent periodic filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings. These statements speak only as of the date of this release, and Cubist undertakes no obligation to update or revise these statements, except as may be required by law.
1 American Pain Society. aChronic Pain In America: Roadblocks To Relief.a [ http://www.ampainsoc.org/resources/roadblocks/conclude_road.htm ]
2 Camilerri M. Am J Gatroenterol. 2011; 106(5):835-42